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FDA 510(k)

TRACH MIST UNIT W/OR WITHOUT ELBOW

K-Number: K800990 · 1980-05-08

ApplicantAirlife, Inc.
Decision Date1980-05-08
Product CodeBYH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH MIST UNIT W/OR WITHOUT ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800990. The device is classified under product code BYH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH MIST UNIT W/OR WITHOUT ELBOW?

TRACH MIST UNIT W/OR WITHOUT ELBOW is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Airlife, Inc.. The 510(k) number is K800990.

When did TRACH MIST UNIT W/OR WITHOUT ELBOW receive FDA 510(k) clearance?

TRACH MIST UNIT W/OR WITHOUT ELBOW received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800990.

Who is the listed applicant for TRACH MIST UNIT W/OR WITHOUT ELBOW?

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 TRACH MIST UNIT W/OR WITHOUT ELBOW?

The FDA product code for TRACH MIST UNIT W/OR WITHOUT ELBOW is BYH.

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Other records listing Airlife, Inc. as applicant

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Related Devices (Code: BYH)

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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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