K952031 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER, MODEL US917. This device is classified as a Transducer, Ultrasonic, Obstetric (Class II - Special Controls, product code HGL).
Submitted by Advanced Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on July 18, 1995, 78 days after receiving the submission on May 1, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2960.
| 510(k) Number | K952031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1995 |
| Decision Date | July 18, 1995 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGL — Transducer, Ultrasonic, Obstetric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2960 |