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FDA 510(k)

AIR ENTRAINMENT TRACH T

K-Number: K810947 · 1981-06-02

ApplicantAirlife, Inc.
Decision Date1981-06-02
Product CodeBYF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR ENTRAINMENT TRACH T is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-06-02 under 510(k) number K810947. 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 AIR ENTRAINMENT TRACH T?

AIR ENTRAINMENT TRACH T is a medical device that received FDA 510(k) clearance on 1981-06-02. The listed applicant is Airlife, Inc.. The 510(k) number is K810947.

When did AIR ENTRAINMENT TRACH T receive FDA 510(k) clearance?

AIR ENTRAINMENT TRACH T received FDA 510(k) clearance on 1981-06-02, under 510(k) number K810947.

Who is the listed applicant for AIR ENTRAINMENT TRACH T?

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 AIR ENTRAINMENT TRACH T?

The FDA product code for AIR ENTRAINMENT TRACH T 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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