Tulsa Pro System (Pad-105)— 510(k) K240296
Substantially EquivalentProfound Medical, Inc.
FDA 510(k) clearance K240296 for Tulsa Pro System (Pad-105), Substantially Equivalent on 2024-05-09. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
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