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FDA 510(k)

MASK, BI FLO NASAL OXYGEN

K-Number: K781741 · 1978-12-01

ApplicantInhal-O-Tech Medical Plastic
Decision Date1978-12-01
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASK, BI FLO NASAL OXYGEN 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 1978-12-01 under 510(k) number K781741. 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, BI FLO NASAL OXYGEN?

MASK, BI FLO NASAL OXYGEN is a medical device that received FDA 510(k) clearance on 1978-12-01. The listed applicant is Inhal-O-Tech Medical Plastic. The 510(k) number is K781741.

When did MASK, BI FLO NASAL OXYGEN receive FDA 510(k) clearance?

MASK, BI FLO NASAL OXYGEN received FDA 510(k) clearance on 1978-12-01, under 510(k) number K781741.

Who is the listed applicant for MASK, BI FLO NASAL OXYGEN?

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, BI FLO NASAL OXYGEN?

The FDA product code for MASK, BI FLO NASAL OXYGEN is BYG.

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.

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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.

K781394DISPOSABLE INCENTIVE SPIROMETERK781395DISPOSABLE AEROSOL T BRIGGS ADAPTORK770354TUBING, AEROSAL, DISPOSABLEK770353DISPOSABLE TEMPERATURE PROBEK760329MASK, DISPOSABLE OXYGEN THERAPYK760330CANNULA, 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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