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FDA 510(k)

ASAHI Corsair Armet

K-Number: K161362 · 2016-06-14

ApplicantAsahi Intecc Co., Ltd.
Decision Date2016-06-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI Corsair Armet is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K161362. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI Corsair Armet?

ASAHI Corsair Armet is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161362.

When did ASAHI Corsair Armet receive FDA 510(k) clearance?

ASAHI Corsair Armet received FDA 510(k) clearance on 2016-06-14, under 510(k) number K161362.

Who is the listed applicant for ASAHI Corsair Armet?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI Corsair Armet?

The FDA product code for ASAHI Corsair Armet is DQY.

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Official Source

View on FDA Database →

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

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