The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson S2000 And S3000 Diagnostic Ultrasound Systems.
| Device ID | K130739 |
| 510k Number | K130739 |
| Device Name: | ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Shelly Pearce |
| Correspondent | Shelly Pearce SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-06-06 |
| Summary: | summary |