K061610 is an FDA 510(k) clearance for the PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS. 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 August 14, 2006, 66 days after receiving the submission on June 9, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K061610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2006 |
| Decision Date | August 14, 2006 |
| Days to Decision | 66 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 |