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FDA 510(k)

COMPACT S, COMPACT S (LED)

K-Number: K170104 · 2017-12-27

ApplicantDmetec.Co., Ltd.
Decision Date2017-12-27
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPACT S, COMPACT S (LED) is the device name listed in this FDA 510(k) record. The listed applicant is Dmetec.Co., Ltd.. It received FDA 510(k) clearance on 2017-12-27 under 510(k) number K170104. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPACT S, COMPACT S (LED)?

COMPACT S, COMPACT S (LED) is a medical device that received FDA 510(k) clearance on 2017-12-27. The listed applicant is Dmetec.Co., Ltd.. The 510(k) number is K170104.

When did COMPACT S, COMPACT S (LED) receive FDA 510(k) clearance?

COMPACT S, COMPACT S (LED) received FDA 510(k) clearance on 2017-12-27, under 510(k) number K170104.

Who is the listed applicant for COMPACT S, COMPACT S (LED)?

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

What is the FDA product code for COMPACT S, COMPACT S (LED)?

The FDA product code for COMPACT S, COMPACT S (LED) is ELC.

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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.

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