FDA 510(k)

Enbio S

K-Number: K213991 · 2022-02-22

Decision Date2022-02-22

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Enbio S is the device name listed in this FDA 510(k) record. The listed applicant is Enbio Group AG. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K213991. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enbio S?

Enbio S is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Enbio Group AG. The 510(k) number is K213991.

When did Enbio S receive FDA 510(k) clearance?

Enbio S received FDA 510(k) clearance on 2022-02-22, under 510(k) number K213991.

Who is the listed applicant for Enbio S?

The FDA 510(k) record lists Enbio Group AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enbio S?

The FDA product code for Enbio S is FLE.

Other records listing Enbio Group AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260254Enbio PRO K210279Enbio S

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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.