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FDA 510(k)

Cuffix

K-Number: K192611 · 2020-08-13

ApplicantBiovo Technologies , Ltd.
Decision Date2020-08-13
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Cuffix is the device name listed in this FDA 510(k) record. The listed applicant is Biovo Technologies , Ltd.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K192611. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cuffix?

Cuffix is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Biovo Technologies , Ltd.. The 510(k) number is K192611.

When did Cuffix receive FDA 510(k) clearance?

Cuffix received FDA 510(k) clearance on 2020-08-13, under 510(k) number K192611.

Who is the listed applicant for Cuffix?

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

What is the FDA product code for Cuffix?

The FDA product code for Cuffix is BSK.

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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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