TULSA-PRO System— 510(k) K211858

Substantially Equivalent

Profound Medical, Inc.

FDA 510(k) clearance K211858 for TULSA-PRO System, Substantially Equivalent on 2022-09-06. Applicant: Profound Medical, Inc..

Clearance details

Applicant: Profound Medical, Inc.
Product code: Code PLP
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-16
Decision date: 2022-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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