The following data is part of a premarket notification filed by Astel Inc. with the FDA for Rfa-1717dig, Rfa-1717dic.
Device ID | K212051 |
510k Number | K212051 |
Device Name: | RFA-1717DIG, RFA-1717DIC |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | ASTEL Inc. 26-79, Gajeongbuk-ro, Yuseong-gu Daejeon, KR 34113 |
Contact | Yonghwan Jeon |
Correspondent | Dave Kim Mtech Group 7505 Fannin St. Ste 610 Houston, TX 77054 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-30 |
Decision Date | 2021-08-25 |