FDA 510(k)

ASAHI Astato XS 40

K-Number: K153443 · 2016-02-25

Decision Date2016-02-25

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Astato XS 40 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 2016-02-25 under 510(k) number K153443. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI Astato XS 40?

ASAHI Astato XS 40 is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K153443.

When did ASAHI Astato XS 40 receive FDA 510(k) clearance?

ASAHI Astato XS 40 received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153443.

Who is the listed applicant for ASAHI Astato XS 40?

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 Astato XS 40?

The FDA product code for ASAHI Astato XS 40 is DQX.

Other records listing Asahi Intecc Co., Ltd. as applicant

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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.