The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan Biocon-900s.
| Device ID | K200749 |
| 510k Number | K200749 |
| Device Name: | CUBEScan BioCon-900S |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro, Jungnang-gu, Seoul, 02048 Korea Seoul, KP 02048 |
| Contact | Hye-ri Choi |
| Correspondent | Hye-ri Choi Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro, Jungnang-gu, Seoul, 02048 Korea Seoul, KP 02048 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2020-05-19 |