K903316 is an FDA 510(k) clearance for the ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER. This device is classified as a Transducer, Ultrasonic, Obstetric (Class II - Special Controls, product code HGL).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on August 22, 1990, 28 days after receiving the submission on July 25, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2960.
| 510(k) Number | K903316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1990 |
| Decision Date | August 22, 1990 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HGL - Transducer, Ultrasonic, Obstetric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2960 |