The following data is part of a premarket notification filed by Ecotron Co., Ltd with the FDA for Dt-703.
| Device ID | K221233 |
| 510k Number | K221233 |
| Device Name: | DT-703 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | ECOTRON Co., Ltd 404, 504, 505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil Geumcheon-Gu, Seoul, KR 08511 |
| Contact | Sang Bong Lee |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St, Suite 610 Houston, TX 77054 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800019200406 | K221233 | 000 |