K955529 is an FDA 510(k) clearance for the CRYTRON SYSTEM. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Mark H. Friedman (Mount Vernon, US). The FDA issued a Cleared decision on June 10, 1996, 189 days after receiving the submission on December 4, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K955529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1995 |
| Decision Date | June 10, 1996 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |