The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight Elite Module Tissue Oximeter.
| Device ID | K180003 |
| 510k Number | K180003 |
| Device Name: | FORE-SIGHT ELITE Module Tissue Oximeter |
| 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 | 2018-01-02 |
| Decision Date | 2018-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103208573 | K180003 | 000 |