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FDA 510(k)

OXYGEN MASK, AIR-ENTRAINMENT

K-Number: K772127 · 1978-01-03

ApplicantSalter Labs
Decision Date1978-01-03
Product CodeBYF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASK, AIR-ENTRAINMENT is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 1978-01-03 under 510(k) number K772127. The device is classified under product code BYF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MASK, AIR-ENTRAINMENT?

OXYGEN MASK, AIR-ENTRAINMENT is a medical device that received FDA 510(k) clearance on 1978-01-03. The listed applicant is Salter Labs. The 510(k) number is K772127.

When did OXYGEN MASK, AIR-ENTRAINMENT receive FDA 510(k) clearance?

OXYGEN MASK, AIR-ENTRAINMENT received FDA 510(k) clearance on 1978-01-03, under 510(k) number K772127.

Who is the listed applicant for OXYGEN MASK, AIR-ENTRAINMENT?

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

What is the FDA product code for OXYGEN MASK, AIR-ENTRAINMENT?

The FDA product code for OXYGEN MASK, AIR-ENTRAINMENT is BYF.

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Other records listing Salter Labs as applicant

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Related Devices (Code: BYF)

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.

K955483TRACH MASK MODEL (245, 246)Hospitak, Inc.K951652VENTIMASK MK IVFlexicare Medical, Ltd.K894457CARNATION TRACHEOSTOMY MASKSDadsun Corp., Ltd.K860873VENTURI MASK/ADULT & PAEDIATRICDhd Medical Products Div. Diemolding Corp.K860874VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICDhd Medical Products Div. Diemolding Corp.K852618OXY-DIALAshai Co. , Ltd.

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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