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FDA 510(k)

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

K-Number: K013421 · 2002-01-08

ApplicantLifeguard Medical Products, Inc.
Decision Date2002-01-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Lifeguard Medical Products, Inc.. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K013421. 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 LIFEGUARD NASAL CPAP MASK AND ACCESSORIES?

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Lifeguard Medical Products, Inc.. The 510(k) number is K013421.

When did LIFEGUARD NASAL CPAP MASK AND ACCESSORIES receive FDA 510(k) clearance?

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES received FDA 510(k) clearance on 2002-01-08, under 510(k) number K013421.

Who is the listed applicant for LIFEGUARD NASAL CPAP MASK AND ACCESSORIES?

The FDA 510(k) record lists Lifeguard Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEGUARD NASAL CPAP MASK AND ACCESSORIES?

The FDA product code for LIFEGUARD NASAL CPAP MASK AND ACCESSORIES is BZD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Lifeguard Medical Products, Inc. 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.

K915296MONOPOLAR ELECTRODEK920471LEVY ARTICULATING RETRACTORK915505REGULATOR FLOWMETERK915297TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MMK915298SUCTION/IRRIGATION CANNULA; CATLOG #532.00K880958LIFEGUARD BACTERIAL AND VIRAL FILTER

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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