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FDA 510(k)

DISPOSABLE TRACH T OXYGENATOR

K-Number: K811890 · 1981-07-15

ApplicantAirlife, Inc.
Decision Date1981-07-15
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TRACH T OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-07-15 under 510(k) number K811890. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE TRACH T OXYGENATOR?

DISPOSABLE TRACH T OXYGENATOR is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Airlife, Inc.. The 510(k) number is K811890.

When did DISPOSABLE TRACH T OXYGENATOR receive FDA 510(k) clearance?

DISPOSABLE TRACH T OXYGENATOR received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811890.

Who is the listed applicant for DISPOSABLE TRACH T OXYGENATOR?

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 DISPOSABLE TRACH T OXYGENATOR?

The FDA product code for DISPOSABLE TRACH T OXYGENATOR is BZA.

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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: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, Inc.

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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