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FDA 510(k)

UNIVERSAL TWO-PIECE MACHINES

K-Number: K791444 · 1979-08-28

ApplicantAirlife, Inc.
Decision Date1979-08-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TWO-PIECE MACHINES is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K791444. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL TWO-PIECE MACHINES?

UNIVERSAL TWO-PIECE MACHINES is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Airlife, Inc.. The 510(k) number is K791444.

When did UNIVERSAL TWO-PIECE MACHINES receive FDA 510(k) clearance?

UNIVERSAL TWO-PIECE MACHINES received FDA 510(k) clearance on 1979-08-28, under 510(k) number K791444.

Who is the listed applicant for UNIVERSAL TWO-PIECE MACHINES?

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 UNIVERSAL TWO-PIECE MACHINES?

The FDA product code for UNIVERSAL TWO-PIECE MACHINES is CAF.

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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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