K014159 is an FDA 510(k) clearance for the PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Philips Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on January 18, 2002, 30 days after receiving the submission on December 19, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K014159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2001 |
| Decision Date | January 18, 2002 |
| Days to Decision | 30 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 |