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FDA 510(k)

ASAHI SASUKE

K-Number: K182844 · 2019-06-22

ApplicantAsahi Intecc Co., Ltd.
Decision Date2019-06-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI SASUKE 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 2019-06-22 under 510(k) number K182844. 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 SASUKE?

ASAHI SASUKE is a medical device that received FDA 510(k) clearance on 2019-06-22. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K182844.

When did ASAHI SASUKE receive FDA 510(k) clearance?

ASAHI SASUKE received FDA 510(k) clearance on 2019-06-22, under 510(k) number K182844.

Who is the listed applicant for ASAHI SASUKE?

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 SASUKE?

The FDA product code for ASAHI SASUKE 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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