The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Model 2001.
Device ID | K934915 |
510k Number | K934915 |
Device Name: | ACUSON MODEL 2001 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
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 | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-15 |
Decision Date | 1994-10-21 |