K926030 is an FDA 510(k) clearance for the KLEAR-TEMP. This device is classified as a Warmer, Infant Radiant (Class II - Special Controls, product code FMT).
Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on February 24, 1994, 450 days after receiving the submission on December 1, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K926030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1992 |
| Decision Date | February 24, 1994 |
| Days to Decision | 450 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMT - Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |