← Back to catalogue
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit …
FDA 510(k)Class II (US FDA 510(k))
510(k) K240447
Identifiers
- 510(k) Number
- K240447 FDA 510(k)
- FDA Product Code
- MLW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5630 FDA 510(k)
- Regulation Number
- 876.5630 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESK Substantially Equivalent — Kit FDA 510(k)
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit … by Thermasolutions, LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240447 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermasolutions, LLC
Sources (1)
- FDA 510(k) K240447 24 fields · synced Jun 18, 2026