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FDA 510(k)

MASK, DISPOSABLE OXYGEN THERAPY

K-Number: K760329 · 1976-09-30

ApplicantInhal-O-Tech Medical Plastic
Decision Date1976-09-30
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASK, DISPOSABLE OXYGEN THERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Inhal-O-Tech Medical Plastic. It received FDA 510(k) clearance on 1976-09-30 under 510(k) number K760329. 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 MASK, DISPOSABLE OXYGEN THERAPY?

MASK, DISPOSABLE OXYGEN THERAPY is a medical device that received FDA 510(k) clearance on 1976-09-30. The listed applicant is Inhal-O-Tech Medical Plastic. The 510(k) number is K760329.

When did MASK, DISPOSABLE OXYGEN THERAPY receive FDA 510(k) clearance?

MASK, DISPOSABLE OXYGEN THERAPY received FDA 510(k) clearance on 1976-09-30, under 510(k) number K760329.

Who is the listed applicant for MASK, DISPOSABLE OXYGEN THERAPY?

The FDA 510(k) record lists Inhal-O-Tech Medical Plastic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASK, DISPOSABLE OXYGEN THERAPY?

The FDA product code for MASK, DISPOSABLE OXYGEN THERAPY is BYG.

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Other records listing Inhal-O-Tech Medical Plastic 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.

K781741MASK, BI FLO NASAL OXYGENK781394DISPOSABLE INCENTIVE SPIROMETERK781395DISPOSABLE AEROSOL T BRIGGS ADAPTORK770354TUBING, AEROSAL, DISPOSABLEK770353DISPOSABLE TEMPERATURE PROBEK760330CANNULA, DISPOSABLE OXYGEN TTHERAPY

View all 7 devices →

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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