The following data is part of a premarket notification filed by Medicore Co., Ltd. with the FDA for Iris-xp.
| Device ID | K212412 |
| 510k Number | K212412 |
| Device Name: | IRIS-XP |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | Medicore Co., Ltd. Seongnam-si, KR 13207 |
| Contact | Kyo-bum Kim |
| Correspondent | Dogyun Lim GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, KR 03909 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-03 |
| Decision Date | 2021-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191237000069 | K212412 | 000 |