The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Model 3001.
| Device ID | K935595 |
| 510k Number | K935595 |
| Device Name: | ACUSON MODEL 3001 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-19 |
| Decision Date | 1995-03-02 |