The following data is part of a premarket notification filed by Intromedic Co., Ltd with the FDA for Mirocam Capsule Endoscope System.
| Device ID | K143663 |
| 510k Number | K143663 |
| Device Name: | MiroCam Capsule Endoscope System |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | INTROMEDIC CO., LTD SUITE 1104 E&C VENTURE DREAM TOWER 6-CHA, 197-28 GURO-DONG Guro-gu , Seoul, KR 152719 |
| Contact | Jinyoung Lee |
| Correspondent | Jinyoung Lee INTROMEDIC CO., LTD SUITE 1104 E&C VENTURE DREAM TOWER 6-CHA, 197-28 GURO-DONG Guro-gu , Seoul, KR 152719 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-23 |
| Decision Date | 2015-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 98809260260446 | K143663 | 000 |
| 08809260260290 | K143663 | 000 |
| 18809260260563 | K143663 | 000 |