K884900 is an FDA 510(k) clearance for the SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Siemens Medical Solutions USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 13, 1989, 51 days after receiving the submission on November 23, 1988.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K884900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1988 |
| Decision Date | January 13, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |