The following data is part of a premarket notification filed by Intromedic Co., Ltd. with the FDA for Mirocam Capsule Endoscope System.
| Device ID | K170438 |
| 510k Number | K170438 |
| Device Name: | MiroCam Capsule Endoscope System |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | IntroMedic Co., Ltd. Suite 1105, 1106, E&C Venture Dream Tower 6-Cha Guro-dong,Guro-gu Seoul, KP 08375 |
| Contact | Jinyoung Lee |
| Correspondent | Jinyoung Lee IntroMedic Co., Ltd. Suite 1105, 1106, E&C Venture Dream Tower 6-Cha Guro-dong,Guro-gu Seoul, KP 08375 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2018-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260260436 | K170438 | 000 |
| 18809260260358 | K170438 | 000 |
| 08809260260191 | K170438 | 000 |
| 18809260260570 | K170438 | 000 |