The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight Absolute Cerebral And Somatic Oximeter, Mc 2000 Series, Models Mc2000, Mc2010, Mc2020, Mc2030.
| Device ID | K094030 |
| 510k Number | K094030 |
| Device Name: | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 |
| 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 | 2009-12-30 |
| Decision Date | 2010-12-23 |
| Summary: | summary |