The following data is part of a premarket notification filed by Meta Systems Co., Ltd. with the FDA for Eq-pex.
| Device ID | K210789 |
| 510k Number | K210789 |
| Device Name: | EQ-PEX |
| Classification | Locator, Root Apex |
| Applicant | Meta Systems Co., Ltd. #1214-18, Sicox Tower 12F, 484, Dunchon-daero, Jungwon-gu Seongnam-si, KR 13229 |
| Contact | Hyejin Park |
| Correspondent | Hyejin Park Meta Systems Co., Ltd. #1214-18, Sicox Tower 12F, 484, Dunchon-daero, Jungwon-gu Seongnam-si, KR 13229 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2021-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809455601167 | K210789 | 000 |
| 08809455602027 | K210789 | 000 |
| 08809455602010 | K210789 | 000 |
| 08809455602003 | K210789 | 000 |
| 08809455601990 | K210789 | 000 |
| 08809455601983 | K210789 | 000 |
| 08809455601976 | K210789 | 000 |
| 08809455601969 | K210789 | 000 |
| 08809455601419 | K210789 | 000 |