Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

K-Number: K190713 · 2019-10-11

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2019-10-11
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) is a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2019-10-11 under approval number K190713. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)?

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K190713.

When was F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) approved by the FDA?

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) received FDA 510(k) clearance on 2019-10-11, under approval number K190713.

What company makes F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)?

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) is manufactured by Fisher & Paykel Healthcare, Ltd..

What is the FDA product code for F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)?

The FDA product code for F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) is BZD.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07588659 Retail-Grade Weighted Blanket Effectiveness on ADHD-related Sleep Disturbances (BEAD) NOT_YET_RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT02543983 Neurobiology of Suicide RECRUITING NCT05053555 High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 31926779 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety. The Journal of emergency medicine (2020) PMID: 30115367 The multiple arrhythmia dataset evaluation database (M.A.D.A.E.). Journal of electrocardiology (2018) PMID: 27660042 A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance (2016)

Other Devices by Fisher & Paykel Healthcare, Ltd.

K161686F&P InfoSmart K161412F&P Brevida™ Nasal Pillows Mask K173193F&P SleepStyle K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) K203449F&P Visairo NIV Mask Range

View all 25 devices →

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, 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.

↑