The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Eco-x Series (eco-x, Eco-x-s).
| Device ID | K211159 |
| 510k Number | K211159 |
| Device Name: | Eco-x Series (eco-x, Eco-x-s) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Myoung-joon Lee |
| Correspondent | Jeon Seounghwa HDX Will Corp. 03162 10F, 29, Insadong 5-gil Jongno-gu, KR 03162 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2021-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200205 | K211159 | 000 |
| 08800005200199 | K211159 | 000 |