FDA 510(k)

wettrust D2care

K-Number: K170797 · 2017-12-06

Decision Date2017-12-06

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

wettrust D2care is the device name listed in this FDA 510(k) record. The listed applicant is Wettrust Korea Co., Ltd.. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K170797. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the wettrust D2care?

wettrust D2care is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Wettrust Korea Co., Ltd.. The 510(k) number is K170797.

When did wettrust D2care receive FDA 510(k) clearance?

wettrust D2care received FDA 510(k) clearance on 2017-12-06, under 510(k) number K170797.

Who is the listed applicant for wettrust D2care?

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

What is the FDA product code for wettrust D2care?

The FDA product code for wettrust D2care is NUC.

Related Devices (Code: NUC)

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Official Source

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