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FDA 510(k)

BIOVER

K-Number: K011208 · 2002-10-02

ApplicantBiover AG
Decision Date2002-10-02
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOVER is the device name listed in this FDA 510(k) record. The listed applicant is Biover AG. It received FDA 510(k) clearance on 2002-10-02 under 510(k) number K011208. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVER?

BIOVER is a medical device that received FDA 510(k) clearance on 2002-10-02. The listed applicant is Biover AG. The 510(k) number is K011208.

When did BIOVER receive FDA 510(k) clearance?

BIOVER received FDA 510(k) clearance on 2002-10-02, under 510(k) number K011208.

Who is the listed applicant for BIOVER?

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

What is the FDA product code for BIOVER?

The FDA product code for BIOVER is DXC.

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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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