K851637 is an FDA 510(k) clearance for the SIRECUST 425, RESPECTIVELY SIRECUST 430. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on July 12, 1985, 84 days after receiving the submission on April 19, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K851637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1985 |
| Decision Date | July 12, 1985 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |