TULSA-PRO System— 510(k) K230692
Substantially EquivalentProfound Medical, Inc.
FDA 510(k) clearance K230692 for TULSA-PRO System, Substantially Equivalent on 2023-09-20. 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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