The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight Elite Tissue Oximeter Module.
| Device ID | K190270 |
| 510k Number | K190270 |
| Device Name: | FORE-SIGHT ELITE Tissue Oximeter Module |
| Classification | Oximeter, Tissue Saturation |
| Applicant | CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 |
| Contact | Ron Jeffrey |
| Correspondent | Ron Jeffrey CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-10-21 |
| Summary: | summary |