K993330 is an FDA 510(k) clearance for the THERMOCHEM-HT SYSTEM. This device is classified as a Warmer, Peritoneal Dialysate (Class II - Special Controls, product code MLW).
Submitted by Hemocleanse, Inc. (West Lafayette, US). The FDA issued a Cleared decision on December 30, 1999, 87 days after receiving the submission on October 4, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K993330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1999 |
| Decision Date | December 30, 1999 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MLW — Warmer, Peritoneal Dialysate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |