LEva Pelvic Digital Health System— 510(k) K192270

Substantially Equivalent

Renovia, Inc.

FDA 510(k) clearance K192270 for LEva Pelvic Digital Health System, Substantially Equivalent on 2019-11-22. Applicant: Renovia, Inc..

Clearance details

Applicant: Renovia, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2019-08-22
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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