The following data is part of a premarket notification filed by H&abyz with the FDA for Had1717mc.
| Device ID | K200018 |
| 510k Number | K200018 |
| Device Name: | HAD1717MC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | H&abyz 1F, 2-dong, 41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu Yongin-si, KR 17118 |
| Contact | Nam Kyu Hur |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-03 |
| Decision Date | 2020-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800070400012 | K200018 | 000 |