TULSA-PRO System— 510(k) K191200

Substantially Equivalent

Profound Medical, Inc.

FDA 510(k) clearance K191200 for TULSA-PRO System, Substantially Equivalent on 2019-08-15. Applicant: Profound Medical, Inc..

Clearance details

Applicant: Profound Medical, Inc.
Product code: Code PLP
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-06
Decision date: 2019-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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