K863042 is an FDA 510(k) clearance for the SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on January 14, 1987, 155 days after receiving the submission on August 12, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K863042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1986 |
| Decision Date | January 14, 1987 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSK — Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |