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

FDA 510(k)

OXYGEN MASK W/RESERVOIR BAG

K-Number: K790161 · 1979-04-20

ApplicantAirlife, Inc.
Decision Date1979-04-20
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASK W/RESERVOIR BAG is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-04-20 under 510(k) number K790161. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MASK W/RESERVOIR BAG?

OXYGEN MASK W/RESERVOIR BAG is a medical device that received FDA 510(k) clearance on 1979-04-20. The listed applicant is Airlife, Inc.. The 510(k) number is K790161.

When did OXYGEN MASK W/RESERVOIR BAG receive FDA 510(k) clearance?

OXYGEN MASK W/RESERVOIR BAG received FDA 510(k) clearance on 1979-04-20, under 510(k) number K790161.

Who is the listed applicant for OXYGEN MASK W/RESERVOIR BAG?

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

What is the FDA product code for OXYGEN MASK W/RESERVOIR BAG?

The FDA product code for OXYGEN MASK W/RESERVOIR BAG is KGB.

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 Airlife, 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.

K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

View all 76 devices →

Related Devices (Code: KGB)

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.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K960401ULTIMATE SEALHans Rudolph, Inc.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, 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.

↑