The following data is part of a premarket notification filed by Intromedic Co., Ltd with the FDA for Mirocam Capsule Endoscope System.
| Device ID | K111450 |
| 510k Number | K111450 |
| Device Name: | MIROCAM CAPSULE ENDOSCOPE SYSTEM |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | INTROMEDIC CO., LTD 40 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Jeffrey Roberts |
| Correspondent | Jeffrey Roberts INTROMEDIC CO., LTD 40 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-25 |
| Decision Date | 2012-05-18 |
| Summary: | summary |