The following data is part of a premarket notification filed by Meta Systems Co., Ltd with the FDA for Eq-m.
| Device ID | K210475 |
| 510k Number | K210475 |
| Device Name: | EQ-M |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Meta Systems Co., Ltd #1214-18, Sicox Tower 12F, 484, Dunchon-daero, Jungwon-gu Seongnam-si, KR 13229 |
| Contact | Yang Ho Dong |
| Correspondent | Yang Ho Dong Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seoul, KR 06253 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-17 |
| Decision Date | 2022-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809455601952 | K210475 | 000 |
| 08809455601945 | K210475 | 000 |
| 08809455601938 | K210475 | 000 |
| 08809455601921 | K210475 | 000 |
| 08809455601402 | K210475 | 000 |
| 08809455600917 | K210475 | 000 |