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FDA 510(k)

PULMOMIST

K-Number: K952326 · 1996-02-27

ApplicantGlobal Medical Ent., Inc.
Decision Date1996-02-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMOMIST is the device name listed in this FDA 510(k) record. The listed applicant is Global Medical Ent., Inc.. It received FDA 510(k) clearance on 1996-02-27 under 510(k) number K952326. 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 PULMOMIST?

PULMOMIST is a medical device that received FDA 510(k) clearance on 1996-02-27. The listed applicant is Global Medical Ent., Inc.. The 510(k) number is K952326.

When did PULMOMIST receive FDA 510(k) clearance?

PULMOMIST received FDA 510(k) clearance on 1996-02-27, under 510(k) number K952326.

Who is the listed applicant for PULMOMIST?

The FDA 510(k) record lists Global Medical Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULMOMIST?

The FDA product code for PULMOMIST is CAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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