Tulsa Pro System (Pad-105)— 510(k) K240296

Substantially Equivalent

Profound Medical, Inc.

FDA 510(k) clearance K240296 for Tulsa Pro System (Pad-105), Substantially Equivalent on 2024-05-09. Applicant: Profound Medical, Inc..

Clearance details

Applicant: Profound Medical, Inc.
Product code: Code PLP
Advisory panel: Gastroenterology, Urology
Date received: 2024-02-01
Decision date: 2024-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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