The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Acuson X300 Ultrasound System.
| Device ID | K080760 |
| 510k Number | K080760 |
| Device Name: | ACUSON X300 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Martina Vogt |
| Correspondent | Martina Vogt SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY Mountain View, CA 94043 |
| Product Code | IYN |
| Subsequent Product Code | DQO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-04-25 |
| Summary: | summary |