K033444 is an FDA 510(k) clearance for the PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on November 21, 2003, 23 days after receiving the submission on October 29, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K033444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2003 |
| Decision Date | November 21, 2003 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |