The following data is part of a premarket notification filed by Mcube Technology Co., Ltd. with the FDA for Cubescan Biocon-1100.
| Device ID | K200548 |
| 510k Number | K200548 |
| Device Name: | CUBEScan BioCon-1100 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro Jungnang-gu, Seoul, Korea Seoul, KR 02048 |
| Contact | Hye-ri Choi |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809458500115 | K200548 | 000 |