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FDA 510(k)

PEDIATRIC OXYGEN OR AEROSOL MASKS,

K-Number: K802323 · 1980-10-03

ApplicantAirlife, Inc.
Decision Date1980-10-03
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC OXYGEN OR AEROSOL MASKS, is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K802323. 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 PEDIATRIC OXYGEN OR AEROSOL MASKS,?

PEDIATRIC OXYGEN OR AEROSOL MASKS, is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Airlife, Inc.. The 510(k) number is K802323.

When did PEDIATRIC OXYGEN OR AEROSOL MASKS, receive FDA 510(k) clearance?

PEDIATRIC OXYGEN OR AEROSOL MASKS, received FDA 510(k) clearance on 1980-10-03, under 510(k) number K802323.

Who is the listed applicant for PEDIATRIC OXYGEN OR AEROSOL MASKS,?

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 PEDIATRIC OXYGEN OR AEROSOL MASKS,?

The FDA product code for PEDIATRIC OXYGEN OR AEROSOL MASKS, 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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