FDA 510(k)

Metacem

K-Number: K171449 · 2018-05-15

Decision Date2018-05-15

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Metacem is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K171449. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Metacem?

Metacem is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K171449.

When did Metacem receive FDA 510(k) clearance?

Metacem received FDA 510(k) clearance on 2018-05-15, under 510(k) number K171449.

Who is the listed applicant for Metacem?

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

What is the FDA product code for Metacem?

The FDA product code for Metacem is EMA.

Other records listing Meta Biomed Co., Ltd. as applicant

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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.