Pelvital System— 510(k) K200409

Substantially Equivalent

Pelvital USA, Inc.

FDA 510(k) clearance K200409 for Pelvital System, Substantially Equivalent on 2020-07-10. Applicant: Pelvital USA, Inc..

Clearance details

Applicant: Pelvital USA, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2020-02-19
Decision date: 2020-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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