K021251 is an FDA 510(k) clearance for the ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on May 7, 2002, 18 days after receiving the submission on April 19, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K021251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2002 |
| Decision Date | May 07, 2002 |
| Days to Decision | 18 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 |