The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Eub-40.
Device ID | K844128 |
510k Number | K844128 |
Device Name: | EUB-40 |
Classification | Monitor, Ultrasonic, Nonfetal |
Applicant | HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
Contact | Richard A Long |
Correspondent | Richard A Long HITACHI MEDICAL CORP. OF AMERICA 50 PROSPECT AVE. Tarrytown, NY 10591 |
Product Code | JAF |
CFR Regulation Number | 892.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-23 |
Decision Date | 1985-02-25 |