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 |