The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Klear-temp.
| Device ID | K926030 | 
| 510k Number | K926030 | 
| Device Name: | KLEAR-TEMP | 
| Classification | Warmer, Infant Radiant | 
| Applicant | CAS MEDICAL SYSTEMS, INC. 29 BUSINESS PARK DR. Branford, CT 06405 | 
| Contact | Edward W Jackson | 
| Correspondent | Edward W Jackson 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 | 1992-12-01 | 
| Decision Date | 1994-02-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  KLEAR-TEMP  74299032  1879159 Dead/Cancelled | CAS Medical Systems, Inc. 1992-07-29 |