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FDA 510(k)

Metacem

K-Number: K171449 · 2018-05-15

ApplicantMeta Biomed Co., Ltd.
Decision Date2018-05-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Metacem is a medical device manufactured by Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2018-05-15 under approval 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. It is manufactured by Meta Biomed Co., Ltd.. The 510(k) number is K171449.

When was Metacem approved by the FDA?

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

What company makes Metacem?

Metacem is manufactured by Meta Biomed Co., Ltd..

What is the FDA product code for Metacem?

The FDA product code for Metacem is EMA.

Other Devices by Meta Biomed Co., Ltd.

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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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