MiroCam Capsule Endoscope System
IntroMedic Co., Ltd.
IntroMedic Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013684328 | 3013684328 | IntroMedic Co., Ltd. | 1 | N | 2026-01-01 | F-RTEK 4F, 11-25, Simin-daero 327 beon-gil Dongan-gu Anyang-si Gyeonggi KR 14055 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 209476 | 2066580581 | K180732 | MiroCam Capsule Endoscope System | NEZ | 2018-11-08 |
| 209476 | 1241202940 | K170438 | MiroCam Capsule Endoscope System | NEZ | 2018-01-30 |
| 209476 | 1675575805 | K143663 | MiroCam Capsule Endoscope System | NEZ | 2015-03-17 |
| 209476 | 1862904166 | K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2014-06-30 |
| 209476 | 1661963037 | K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | EOX | 2013-06-21 |
| 209476 | 1886960109 | K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | NEZ | 2013-05-20 |
| 209476 | 1408870026 | K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | EOX | 2012-06-20 |
Product Codes Associated With Registrations#
PMN#
MiroCam Capsule Endoscope System
IntroMedic Co., Ltd.
GUDID#
MiroCam Capsule Endoscope System - MC1200-B
2020-09-09
MiroCam Capsule Endoscope System - MC2000-B
2020-09-09
MiroCam Capsule Endoscope System - MC1600-B
2020-09-09
MiroCam Capsule Endoscope System - MC1200-B
2020-09-09
MiroCam Capsule Endoscope System - MC2000-B
2020-09-09
MiroCam Capsule Endoscope System - MC1600-B
2020-09-09
MiroCam Capusle Endoscope System - MC2000-B
2018-02-12
MiroCam Capsule Endoscope System - Package system(MC1200-B capsule, MR2000 receiver)
2018-03-12
MiroCam Capsule Endoscope System - MR2000
2018-02-12
MiroCam Capsule Endoscope System - MC1000-B
2017-01-31
MiroCam Capsule Endoscope System - MC1200-B
2017-01-31
MiroCam Capusle Endoscope System - Package System(MC2000-B Capsule and MR2000 Receiver)
2018-02-12
MiroCam Capsule Endoscope System - MC1600-B
2019-06-17
MiroCam Capsule Endoscope System - Package system(MC1600-B Capsule and MR2000 Receiver)
2019-06-17
MiroCam Capusle Endoscope System - MC2000-B
2018-02-12
MiroCam Capsule Endoscope System - Package system(MC1200-B capsule, MR2000 receiver)
2018-03-12
MiroCam Capsule Endoscope System - MR1100
2017-01-31
MiroCam Capsule Endoscope System - Package System(MC1000-B Capsule and MR1100 Receiver)
2017-01-31
MiroCam Capsule Endoscope System - Package (MC1200-B Capsule and MR1100 Receiver)
2017-01-31
MiroCam Capsule Endoscope System - MR1000-D(M)
2017-12-05
MiroCam Capsule Endoscope System - MR1000-D(L)
2017-12-05
MiroCam Capsule Endoscope System - MR1000-S
2017-12-05