The following data is part of a premarket notification filed by Intromedic Co., Ltd with the FDA for Mirocam Capsule Endoscope System.
| Device ID | K123428 |
| 510k Number | K123428 |
| Device Name: | MIROCAM CAPSULE ENDOSCOPE SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | INTROMEDIC CO., LTD STE 1104, E&C VENTURE DREAM TOWER 6-CHA 197-28 GURO-DONG Guro-gu , Seoul, KR 152-719 |
| Contact | Steve Kwon |
| Correspondent | Steve Kwon INTROMEDIC CO., LTD STE 1104, E&C VENTURE DREAM TOWER 6-CHA 197-28 GURO-DONG Guro-gu , Seoul, KR 152-719 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-07 |
| Decision Date | 2013-05-20 |
| Summary: | summary |