Submission Details
| 510(k) Number | K072070 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2007 |
| Decision Date | August 10, 2007 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K072070 is an FDA 510(k) clearance for the PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on August 10, 2007, 11 days after receiving the submission on July 30, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K072070 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2007 |
| Decision Date | August 10, 2007 |
| Days to Decision | 11 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 |