The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Aloka Ust-964p-5 Endovaginal Transducer.
| Device ID | K903316 |
| 510k Number | K903316 |
| Device Name: | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Brain R Barry |
| Correspondent | Brain R Barry GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-08-22 |