The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Sequoia Signature Ii Diagnostic Ultrasound System.
| Device ID | K022567 |
| 510k Number | K022567 |
| Device Name: | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Contact | Jerry W Tsutsumi |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-08-13 |
| Summary: | summary |