The following data is part of a premarket notification filed by Digimed Co., Ltd. with the FDA for Hybrid S70.
| Device ID | K220574 |
| 510k Number | K220574 |
| Device Name: | HYBRID S70 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Digimed Co., LTD. 145, Gasan Digital 1-ro, Geumcheon-gu Seoul, KR 08506 |
| Contact | Youngbae Kwon |
| Correspondent | Youngbae Kwon Digimed Co., LTD. 145, Gasan Digital 1-ro, Geumcheon-gu Seoul, KR 08506 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-04-22 |