The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Neoguard Reflector.
| Device ID | K853794 |
| 510k Number | K853794 |
| Device Name: | NEOGUARD REFLECTOR |
| Classification | Warmer, Infant Radiant |
| Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Joel N Helfer |
| Correspondent | Joel N Helfer CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-11 |
| Decision Date | 1985-10-16 |