The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd. with the FDA for X-cube 70.
| Device ID | K211299 |
| 510k Number | K211299 |
| Device Name: | X-CUBE 70 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Alpinion Medical Systems Co., Ltd. 5FL, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si, KR 14117 |
| Contact | Boyeon Cho |
| Correspondent | Boyeon Cho Alpinion Medical Systems Co., Ltd. 5FL, I Dong, 77, Heungan-daero 81 Beon-gil Dongan-gu Anyang-si, KR 14117 |
| 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 | 2021-04-28 |
| Decision Date | 2021-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013511157 | K211299 | 000 |
| 08800013510211 | K211299 | 000 |
| 08800013510174 | K211299 | 000 |