K113125 is an FDA 510(k) clearance for the INTELLIVUE MX40 PATIENT MONITOR. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on November 17, 2011, 24 days after receiving the submission on October 24, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K113125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2011 |
| Decision Date | November 17, 2011 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |