510(k) K131583
- Device
- THERMOCHEM HT-2000
- Applicant
- THERMASOLUTIONS, INC.
- 510(k) number
- K131583
- Product code
- MLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-10-03
- Date received
- 2013-05-31
- Regulation
- 876.5630
- Classification name
- Warmer, Peritoneal Dialysate
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- M.W. ANDY ANDERSON PH.D. RAC
- Address
- 5353 Wayzata Blvd. Suite 505 Minneapolis MN US 55416 55416
FDA Registration Numbers#
- 3005699784
- 3012706378
- 3014377913
- 3006986257
- 3003661577
Source Documents#
Other 510(k) Records For Product Code MLW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC | 2025-05-05 |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Stickman Industries, Inc. | 2002-09-27 |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 |
| K964825 | FREEDOM TRAVELLER | Impact Case Technologies, Inc. | 1997-05-19 |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases