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FDA 510(k)

NEBULIZER WITH AIR ENTERTAINER & ETC.

K-Number: K801252 · 1980-06-04

ApplicantAirlife, Inc.
Decision Date1980-06-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER WITH AIR ENTERTAINER & ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801252. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEBULIZER WITH AIR ENTERTAINER & ETC.?

NEBULIZER WITH AIR ENTERTAINER & ETC. is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Airlife, Inc.. The 510(k) number is K801252.

When did NEBULIZER WITH AIR ENTERTAINER & ETC. receive FDA 510(k) clearance?

NEBULIZER WITH AIR ENTERTAINER & ETC. received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801252.

Who is the listed applicant for NEBULIZER WITH AIR ENTERTAINER & ETC.?

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 NEBULIZER WITH AIR ENTERTAINER & ETC.?

The FDA product code for NEBULIZER WITH AIR ENTERTAINER & ETC. is BTT.

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Other records listing Airlife, Inc. as applicant

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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: BTT)

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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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