K850145 is an FDA 510(k) clearance for the CARDIAC SECTOR PROBE 3.5. MHZ. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 10, 1985, 86 days after receiving the submission on January 14, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K850145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1985 |
| Decision Date | April 10, 1985 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | JOP — Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |