K033305 is an FDA 510(k) clearance for the INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on October 31, 2003, 17 days after receiving the submission on October 14, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K033305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2003 |
| Decision Date | October 31, 2003 |
| Days to Decision | 17 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 |