Home / 510(k) Clearances / K131583

510(k) K131583

THERMOCHEM HT-2000 by Thermasolutions, Inc. — Product Code MLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2013
Date Received
May 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Peritoneal Dialysate
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Thermasolutions, Inc.

  • K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit ( (May 5, 2025)
  • K222575 — HurriChem Device Kit (December 6, 2022)

Other clearances for product code MLW

  • K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit ( (May 5, 2025)
  • K020542 — DAYTRIPPER DIALYSATE WARMER (September 27, 2002)
  • K993330 — THERMOCHEM-HT SYSTEM (December 30, 1999)
  • K964825 — FREEDOM TRAVELLER (May 19, 1997)
  • K933619 — PD-PAK (February 22, 1994)