K926099 is an FDA 510(k) clearance for the DATASCOPE 6000 MONITOR. This device is classified as a Monitor, St Segment (Class II - Special Controls, product code MLC).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 6, 1993, 246 days after receiving the submission on December 3, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K926099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1992 |
| Decision Date | August 06, 1993 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MLC - Monitor, St Segment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |