The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-450 Diagnostic Ultrasound Device.
Device ID | K874211 |
510k Number | K874211 |
Device Name: | EUB-450 DIAGNOSTIC ULTRASOUND DEVICE |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
Contact | Uehara |
Correspondent | Uehara HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-16 |
Decision Date | 1988-06-23 |