The following data is part of a premarket notification filed by H&abyz Co., Ltd. with the FDA for Add.
| Device ID | K203188 |
| 510k Number | K203188 |
| Device Name: | ADD |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | H&abyz Co., Ltd. 1F, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu Yongin-si, KR 17118 |
| Contact | Namkyu Hur |
| Correspondent | Im Do Gyun GMS Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul, KR 03909 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-27 |
| Decision Date | 2021-03-12 |