510(k) K123428 ยท NEZ System, Imaging, Gastrointestinal, Wireless, Capsule
MIROCAM CAPSULE ENDOSCOPE SYSTEM
| Applicant | Intromedic Co., Ltd., Guro-Gu , Seoul, KR |
| Decision | Substantially Equivalent, May 20, 2013 |
| Received | Nov 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2017 | IntroMedic Co., Ltd. Miriam Capsule Endoscope System. Model MR1100
Product Usage:
MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abn Terminated |
NEZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.