The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Add'l Transducer For Use W/eub-165 Ultrasound.
Device ID | K901658 |
510k Number | K901658 |
Device Name: | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND |
Classification | Echocardiograph |
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 | DXK |
CFR Regulation Number | 870.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-10 |
Decision Date | 1990-09-04 |