The following data is part of a premarket notification filed by Thermasolutions, Inc. with the FDA for Thermochem Ht-2000.
| Device ID | K131583 |
| 510k Number | K131583 |
| Device Name: | THERMOCHEM HT-2000 |
| Classification | Warmer, Peritoneal Dialysate |
| Applicant | THERMASOLUTIONS, INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis, MN 55416 |
| Contact | M.w. Andy Anderson Ph.d. Rac |
| Correspondent | M.w. Andy Anderson Ph.d. Rac THERMASOLUTIONS, INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis, MN 55416 |
| Product Code | MLW |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-10-03 |
| Summary: | summary |