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FDA 510(k)

AIRSONNETT AIRSHOWER AIR 3

K-Number: K081062 · 2008-11-07

ApplicantAirsonett, Inc.
Decision Date2008-11-07
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIRSONNETT AIRSHOWER AIR 3 is the device name listed in this FDA 510(k) record. The listed applicant is Airsonett, Inc.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K081062. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRSONNETT AIRSHOWER AIR 3?

AIRSONNETT AIRSHOWER AIR 3 is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Airsonett, Inc.. The 510(k) number is K081062.

When did AIRSONNETT AIRSHOWER AIR 3 receive FDA 510(k) clearance?

AIRSONNETT AIRSHOWER AIR 3 received FDA 510(k) clearance on 2008-11-07, under 510(k) number K081062.

Who is the listed applicant for AIRSONNETT AIRSHOWER AIR 3?

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

What is the FDA product code for AIRSONNETT AIRSHOWER AIR 3?

The FDA product code for AIRSONNETT AIRSHOWER AIR 3 is FRF.

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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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