K962827 is an FDA 510(k) clearance for the ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU). 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 February 24, 1997, 220 days after receiving the submission on July 19, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K962827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1996 |
| Decision Date | February 24, 1997 |
| Days to Decision | 220 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 |