K912722 is an FDA 510(k) clearance for the HYPER-K HEAT SYSTEM. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on September 11, 1991, 85 days after receiving the submission on June 18, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K912722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1991 |
| Decision Date | September 11, 1991 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |