The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eup-v12 5.0 Mhz Convex Array Transvaginal Probe.
| Device ID | K900966 |
| 510k Number | K900966 |
| Device Name: | EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Contact | Takiguchi |
| Correspondent | Takiguchi HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-01 |
| Decision Date | 1990-09-12 |