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FDA 510(k)

OXYGEN MASK, ADULT VINYL

K-Number: K790166 · 1979-03-16

ApplicantAirlife, Inc.
Decision Date1979-03-16
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASK, ADULT VINYL is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-03-16 under 510(k) number K790166. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MASK, ADULT VINYL?

OXYGEN MASK, ADULT VINYL is a medical device that received FDA 510(k) clearance on 1979-03-16. The listed applicant is Airlife, Inc.. The 510(k) number is K790166.

When did OXYGEN MASK, ADULT VINYL receive FDA 510(k) clearance?

OXYGEN MASK, ADULT VINYL received FDA 510(k) clearance on 1979-03-16, under 510(k) number K790166.

Who is the listed applicant for OXYGEN MASK, ADULT VINYL?

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, ADULT VINYL?

The FDA product code for OXYGEN MASK, ADULT VINYL is BYG.

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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

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Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

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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