The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd with the FDA for E-cube 7.
| Device ID | K121729 |
| 510k Number | K121729 |
| Device Name: | E-CUBE 7 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALPINION MEDICAL SYSTEMS CO., LTD SUITE 226, 10604 NE 38TH PLACE Kirkland, WA 98033 |
| Contact | Yuchi Chu |
| Correspondent | Yuchi Chu ALPINION MEDICAL SYSTEMS CO., LTD SUITE 226, 10604 NE 38TH PLACE Kirkland, WA 98033 |
| 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 | 2012-06-12 |
| Decision Date | 2012-09-20 |
| Summary: | summary |