The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson V328 And C5432 Transducers.
Device ID | K897151 |
510k Number | K897151 |
Device Name: | ACUSON V328 AND C5432 TRANSDUCERS |
Classification | Transport Systems, Anaerobic |
Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Contact | Stephen T Johnson |
Correspondent | Stephen T Johnson ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
Product Code | JTX |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-26 |
Decision Date | 1990-07-03 |