K012531 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on November 2, 2001, 88 days after receiving the submission on August 6, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K012531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2001 |
| Decision Date | November 02, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |