K974492 is an FDA 510(k) clearance for the SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS. This device is classified as a Monitor, St Segment With Alarm (Class II - Special Controls, product code MLD).
Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on February 26, 1998, 90 days after receiving the submission on November 28, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K974492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1997 |
| Decision Date | February 26, 1998 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLD — Monitor, St Segment With Alarm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |