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FDA 510(k)

AIRGENT, MODEL AG7000010

K-Number: K082138 · 2009-01-23

ApplicantPerfaction, Inc.
Decision Date2009-01-23
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIRGENT, MODEL AG7000010 is the device name listed in this FDA 510(k) record. The listed applicant is Perfaction, Inc.. It received FDA 510(k) clearance on 2009-01-23 under 510(k) number K082138. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRGENT, MODEL AG7000010?

AIRGENT, MODEL AG7000010 is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Perfaction, Inc.. The 510(k) number is K082138.

When did AIRGENT, MODEL AG7000010 receive FDA 510(k) clearance?

AIRGENT, MODEL AG7000010 received FDA 510(k) clearance on 2009-01-23, under 510(k) number K082138.

Who is the listed applicant for AIRGENT, MODEL AG7000010?

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

What is the FDA product code for AIRGENT, MODEL AG7000010?

The FDA product code for AIRGENT, MODEL AG7000010 is KZE.

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Related Devices (Code: KZE)

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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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