The following data is part of a premarket notification filed by Dms Co., Ltd. with the FDA for Anycheck Imt-100.
| Device ID | K180953 |
| 510k Number | K180953 |
| Device Name: | AnyCheck IMT-100 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DMS Co., Ltd. #201 #202 & #204, Oriental Medical Industry Development Center Wonju-si, KR 26339 |
| Contact | Guntae Kim |
| Correspondent | Hwi Joon Park Allura Medical Solution, Inc. 8141 Lampson Ave. #4 Garden Grove, CA 92841 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-11 |
| Decision Date | 2019-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800038700000 | K180953 | 000 |