The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for E-cube 8.
| Device ID | K181617 |
| 510k Number | K181617 |
| Device Name: | E-CUBE 8 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Alpinion Medical Systems Co., Ltd. 1FL And 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul, KR 08393 |
| Contact | Boyeon Cho |
| Correspondent | Boyeon Cho Alpinion Medical Systems Co., Ltd. 1FL And 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul, KR 08393 |
| 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 | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-10-11 |
| Summary: | summary |