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FDA 510(k)

ASAHI Fielder XT-A, ASAHI Fielder XT-R

K-Number: K153106 · 2016-06-21

ApplicantAsahi Intecc Co., Ltd.
Decision Date2016-06-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI Fielder XT-A, ASAHI Fielder XT-R is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-06-21 under approval number K153106. 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 Fielder XT-A, ASAHI Fielder XT-R?

ASAHI Fielder XT-A, ASAHI Fielder XT-R is a medical device that received FDA 510(k) clearance on 2016-06-21. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K153106.

When was ASAHI Fielder XT-A, ASAHI Fielder XT-R approved by the FDA?

ASAHI Fielder XT-A, ASAHI Fielder XT-R received FDA 510(k) clearance on 2016-06-21, under approval number K153106.

What company makes ASAHI Fielder XT-A, ASAHI Fielder XT-R?

ASAHI Fielder XT-A, ASAHI Fielder XT-R is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI Fielder XT-A, ASAHI Fielder XT-R?

The FDA product code for ASAHI Fielder XT-A, ASAHI Fielder XT-R is DQX.

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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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