The following data is part of a premarket notification filed by Micro-nx Co., Ltd with the FDA for Meg-torq.
| Device ID | K161500 |
| 510k Number | K161500 |
| Device Name: | MEG-TORQ |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | MICRO-NX Co., Ltd 37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun Daegu, KR 711-891 |
| Contact | J. K. Jung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92606 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2017-02-22 |
| Summary: | summary |