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 |