K012837 is an FDA 510(k) clearance for the MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES. This device is classified as a Monitor, St Segment With Alarm (Class II - Special Controls, product code MLD).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on September 14, 2001, 22 days after receiving the submission on August 23, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K012837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2001 |
| Decision Date | September 14, 2001 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLD — Monitor, St Segment With Alarm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |