K240447
- 510(k) number
- K240447
- Device name
- ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
- Applicant
- Thermasolutions, LLC MN · US
- Product code
- MLW — Warmer, Peritoneal Dialysate
- Decision date
- 2025-05-05
- Date received
- 2024-02-15
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K240447.pdf
Official FDA record: K240447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.