K942196 is an FDA 510(k) clearance for the 3050 DIASCOPE NT PATIENT MONITOR. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by S & W Medico Teknik A/S (Albertslund, DK). The FDA issued a Cleared decision on June 28, 1995, 420 days after receiving the submission on May 4, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K942196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1994 |
| Decision Date | June 28, 1995 |
| Days to Decision | 420 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 |