Class Class II

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (K240447)

K240447 2025-05-05 Traditional
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Description

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) by Thermasolutions, LLC, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240447
Clearance Date2025-05-05
Clearance TypeTraditional
Product CodeMLW
Regulation Number876.5630

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