The following data is part of a premarket notification filed by Sota Precision Optics, Inc. Dba Sota Imaging with the FDA for Clio Prime And Clio Pedo.
| Device ID | K202664 |
| 510k Number | K202664 |
| Device Name: | Clio Prime And Clio Pedo |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Sota Precision Optics, Inc. Dba SOTA Imaging 1073 North Batavia Street, Suite B Orange, CA 92867 |
| Contact | Bumsuk Kim |
| Correspondent | Ed Johansen W. Edward Johansen 1239 Stanford Street, #205 Santa Monica, CA 90404 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2020-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851159007118 | K202664 | 000 |
| 00851159007101 | K202664 | 000 |