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FDA 510(k)

AKITA2 APIXNEB

K-Number: K072019 · 2007-11-05

ApplicantActivaero America, Inc.
Decision Date2007-11-05
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AKITA2 APIXNEB is the device name listed in this FDA 510(k) record. The listed applicant is Activaero America, Inc.. It received FDA 510(k) clearance on 2007-11-05 under 510(k) number K072019. 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 AKITA2 APIXNEB?

AKITA2 APIXNEB is a medical device that received FDA 510(k) clearance on 2007-11-05. The listed applicant is Activaero America, Inc.. The 510(k) number is K072019.

When did AKITA2 APIXNEB receive FDA 510(k) clearance?

AKITA2 APIXNEB received FDA 510(k) clearance on 2007-11-05, under 510(k) number K072019.

Who is the listed applicant for AKITA2 APIXNEB?

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

What is the FDA product code for AKITA2 APIXNEB?

The FDA product code for AKITA2 APIXNEB is CAF.

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Other records listing Activaero America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090730AKITA JETK080100WATCHHALER

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Official Source

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