K915153 is an FDA 510(k) clearance for the ESCORT-LINK ARRHYTHMIA OPTION 23L. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on April 27, 1992, 165 days after receiving the submission on November 14, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K915153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1991 |
| Decision Date | April 27, 1992 |
| Days to Decision | 165 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 |