K041235 is an FDA 510(k) clearance for the PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 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 June 4, 2004, 24 days after receiving the submission on May 11, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K041235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2004 |
| Decision Date | June 04, 2004 |
| Days to Decision | 24 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 |