K961139 is an FDA 510(k) clearance for the EAGLE PATIENT MONITOR MODEL 3000/3100. 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 August 9, 1996, 141 days after receiving the submission on March 21, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K961139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1996 |
| Decision Date | August 09, 1996 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |