Tulsa-Pro System— 510(k) K202286

Substantially Equivalent

Profound Medical, Inc.

FDA 510(k) clearance K202286 for Tulsa-Pro System, Substantially Equivalent on 2020-09-16. Applicant: Profound Medical, Inc.. Device class: 2.

Clearance details

Applicant: Profound Medical, Inc.
Product code: Code PLP
Device class: Class 2
Regulation: 21 CFR 876.4340
Advisory panel: Gastroenterology, Urology
Date received: 2020-08-12
Decision date: 2020-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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