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FDA 510(k)

AKITA JET

K-Number: K090730 · 2009-11-13

ApplicantActivaero America, Inc.
Decision Date2009-11-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AKITA JET 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 2009-11-13 under 510(k) number K090730. 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 AKITA JET?

AKITA JET is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Activaero America, Inc.. The 510(k) number is K090730.

When did AKITA JET receive FDA 510(k) clearance?

AKITA JET received FDA 510(k) clearance on 2009-11-13, under 510(k) number K090730.

Who is the listed applicant for AKITA JET?

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 AKITA JET?

The FDA product code for AKITA JET 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.

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Related Devices (Code: CAF)

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.

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Official Source

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