The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson S228 Transducer For Transcranial Color Dopp.
| Device ID | K902515 |
| 510k Number | K902515 |
| Device Name: | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP |
| 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 | 1990-06-05 |
| Decision Date | 1992-09-04 |