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FDA 510(k)

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small

K-Number: K170367 · 2017-08-24

ApplicantFisher and Paykel Healthcare Limited
Decision Date2017-08-24
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is the device name listed in this FDA 510(k) record. The listed applicant is Fisher and Paykel Healthcare Limited. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K170367. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Fisher and Paykel Healthcare Limited. The 510(k) number is K170367.

When did Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small receive FDA 510(k) clearance?

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small received FDA 510(k) clearance on 2017-08-24, under 510(k) number K170367.

Who is the listed applicant for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

The FDA 510(k) record lists Fisher and Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small?

The FDA product code for Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small is MNT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03554863High Flow Oxygen in Patients Undergoing Surgery Under General AnesthesiaCOMPLETEDNCT07222410Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the HospitalRECRUITINGNCT06355713Improvement of Symptoms After Removal of the Essure® Contraceptive ImplantRECRUITINGNCT07071935A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)RECRUITINGNCT07524517NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn InfantsRECRUITINGNCT04230694Continuous Glucose Monitoring of Hospitalized Patients With DiabetesCOMPLETED

Other records listing Fisher and Paykel Healthcare Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

Related Devices (Code: MNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K240779Vivo 3Breas Medical ABK233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K230173Servo-air Lite Ventilator SystemMaquet Critical Care ABK213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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