Data / Medical devices / South Korea / IntroMedic Co., Ltd.
IntroMedic Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 3 510(k) clearances
IntroMedic Co., Ltd. is registered with the FDA (registration 3013684328) in Anyang-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013684328
- Address
- F-RTEK 4F, 11-25, Simin-daero 327 beon-gil Dongan-gu, Anyang-si Gyeonggi, South Korea, 14055
- Owner or operator
- IntroMedic Co., Ltd. (10027343)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 2, 2015
- Registered through
- 2026
- Brand names listed
- Data Belt: MR1000-D(S), MR1000-D(M), MR1000-D(L), Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L), Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L), Data Cable: MR1000-D, MiroCam Capsule Endoscope System, MiroCam Capsule: MC1200-B, MiroCam Capsule: MC1600-B, MiroCam Capsule: MC2000-B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Gastrointestinal, Wireless, Capsule | NEZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2018 | K180732 | MiroCam Capsule Endoscope System | NEZ | Substantially Equivalent | Intromedic Co., Ltd. | accessdata.fda.gov |
| January 30, 2018 | K170438 | MiroCam Capsule Endoscope System | NEZ | Substantially Equivalent | Intromedic Co., Ltd. | accessdata.fda.gov |
| March 17, 2015 | K143663 | MiroCam Capsule Endoscope System | NEZ | Substantially Equivalent | Intromedic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.