K000647 is an FDA 510(k) clearance for the DATEX-OHMEDA NETWORK AND CENTRAL. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on July 13, 2000, 136 days after receiving the submission on February 28, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K000647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2000 |
| Decision Date | July 13, 2000 |
| Days to Decision | 136 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 |