The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Ust-974-5 Convex Transducer.
| Device ID | K911309 |
| 510k Number | K911309 |
| Device Name: | UST-974-5 CONVEX TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-04-29 |