| Device ID | K133505 |
| 510k Number | K133505 |
| Device Name: | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL Gangnam-gu, Seoul, KR 135-280 |
| Contact | Park Kyeong-mi |
| 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 | 2013-11-14 |
| Decision Date | 2013-12-27 |
| Summary: | summary |