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FDA 510(k)

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN

K-Number: K812066 · 1981-08-03

ApplicantAirlife, Inc.
Decision Date1981-08-03
Product CodeBYF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-08-03 under 510(k) number K812066. 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 PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN?

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Airlife, Inc.. The 510(k) number is K812066.

When did PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN receive FDA 510(k) clearance?

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN received FDA 510(k) clearance on 1981-08-03, under 510(k) number K812066.

Who is the listed applicant for PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN?

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 PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN?

The FDA product code for PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN is BYF.

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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: 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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