K081793 is an FDA 510(k) clearance for the PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, Bw, DE). The FDA issued a Cleared decision on October 14, 2008, 111 days after receiving the submission on June 25, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K081793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2008 |
| Decision Date | October 14, 2008 |
| Days to Decision | 111 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 |