The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight Elite Absolute Tissue Oximeter.
| Device ID | K133879 |
| 510k Number | K133879 |
| Device Name: | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER |
| Classification | Oximeter, Tissue Saturation |
| Applicant | CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. Branford, CT 06405 |
| Contact | Ron Jeffrey |
| Correspondent | Ron Jeffrey CAS MEDICAL SYSTEMS, INC. 44 EAST INDUSTRIAL RD. 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 | 2013-12-20 |
| Decision Date | 2014-04-29 |
| Summary: | summary |