The following data is part of a premarket notification filed by Cas Medical Systems, Inc. with the FDA for Fore-sight, Model Mc-2000 Series (mc-2000, Mc-2010, Mc2020, Mc2030).
| Device ID | K083892 |
| 510k Number | K083892 |
| Device Name: | FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-03-19 |
| Summary: | summary |