THERMOCHEM HT-2000— 510(k) K131583
Substantially EquivalentThermasolutions, Inc.
FDA 510(k) clearance K131583 for THERMOCHEM HT-2000, Substantially Equivalent on 2013-10-03. Applicant: Thermasolutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Thermasolutions, Inc.
- Product code
- Code MLW
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code MLW
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