K885061 is an FDA 510(k) clearance for the SIEMENS INTRAVAGINAL TRANSDUCER. This device is classified as a Imager, Ultrasonic Obstetric-gynecologic (Class II - Special Controls, product code HEM).
Submitted by Siemens Medical Solutions USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 23, 1989, 79 days after receiving the submission on December 6, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2225.
| 510(k) Number | K885061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1988 |
| Decision Date | February 23, 1989 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HEM — Imager, Ultrasonic Obstetric-gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2225 |