K993531 is an FDA 510(k) clearance for the PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on January 13, 2000, 87 days after receiving the submission on October 18, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K993531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1999 |
| Decision Date | January 13, 2000 |
| Days to Decision | 87 days |
| Submission Type | Abbreviated |
| 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 |