K853794 is an FDA 510(k) clearance for the NEOGUARD REFLECTOR. 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 October 16, 1985, 35 days after receiving the submission on September 11, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5130.
| 510(k) Number | K853794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1985 |
| Decision Date | October 16, 1985 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | FMT - Warmer, Infant Radiant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5130 |