K960418 is an FDA 510(k) clearance for the EAGLE PATIENT MONITOR. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 2, 1996, 247 days after receiving the submission on January 29, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K960418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1996 |
| Decision Date | October 02, 1996 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| 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 |