K910153 is an FDA 510(k) clearance for the UST-974-5 CONVEX TRANSDUCER. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on March 29, 1991, 74 days after receiving the submission on January 14, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K910153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1991 |
| Decision Date | March 29, 1991 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | KNG - Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |