K050844 is an FDA 510(k) clearance for the 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL. 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 June 23, 2005, 80 days after receiving the submission on April 4, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K050844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2005 |
| Decision Date | June 23, 2005 |
| 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 |