K060221 is an FDA 510(k) clearance for the THE PHILLIPS, 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, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on February 17, 2006, 18 days after receiving the submission on January 30, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K060221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2006 |
| Decision Date | February 17, 2006 |
| Days to Decision | 18 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 |