K002105 is an FDA 510(k) clearance for the SIEMENS INFINITY SC 6002XL 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 December 5, 2000, 146 days after receiving the submission on July 12, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K002105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2000 |
| Decision Date | December 05, 2000 |
| Days to Decision | 146 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 |