The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson P500 Ultrasound System.
| Device ID | K213487 |
| 510k Number | K213487 |
| Device Name: | ACUSON P500 Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 |
| Contact | Sulgue Choi |
| Correspondent | Sulgue Choi Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OBJ |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-29 |
| Decision Date | 2022-02-11 |