The following data is part of a premarket notification filed by Remedi Co. Ltd. with the FDA for R-sensor, R-sensor.
| Device ID | K200284 |
| 510k Number | K200284 |
| Device Name: | R-Sensor, R-Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Remedi Co. Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-ro 21 Seoul, KR |
| Contact | Jadon Koo |
| Correspondent | W. Lee Strong 510K FDA Inc. 100 E Granada Blvd, Suite 219 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800060100069 | K200284 | 000 |
| 08800060100052 | K200284 | 000 |