K992323 is an FDA 510(k) clearance for the DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES. This device is classified as a Monitor, St Segment With Alarm (Class II - Special Controls, product code MLD).
Submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on November 1, 1999, 112 days after receiving the submission on July 12, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K992323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1999 |
| Decision Date | November 01, 1999 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MLD — Monitor, St Segment With Alarm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |