K083892 is an FDA 510(k) clearance for the FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 19, 2009, 80 days after receiving the submission on December 29, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K083892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2008 |
| Decision Date | March 19, 2009 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |