The following data is part of a premarket notification filed by Remedi Co. Ltd. with the FDA for Remex Ka6.
| Device ID | K212144 |
| 510k Number | K212144 |
| Device Name: | Remex KA6 |
| Classification | System, X-ray, Mobile |
| Applicant | Remedi Co. Ltd. #1409, IS BIZ Tower, 26 Yangpyeong-RO 21-GIL Seoul, KR 072nn |
| Contact | Suho Cho |
| Correspondent | W. Lee Strong 510K FDA Inc. 100 E Granada Blvd, Suite 219 Ormond Beach, FL 32176 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2021-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800060100151 | K212144 | 000 |
| 08800060100236 | K212144 | 000 |
| 08800060100243 | K212144 | 000 |