Cuffix— 510(k) K192611

Substantially Equivalent

Biovo Technologies , Ltd.

FDA 510(k) clearance K192611 for Cuffix, Substantially Equivalent on 2020-08-13. Applicant: Biovo Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Biovo Technologies , Ltd.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2019-09-20
Decision date: 2020-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosh Haayin, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.