The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Aloka Ust-964p-5 Endovaginal Transducer.
| Device ID | K905000 |
| 510k Number | K905000 |
| Device Name: | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-31 |