Data / Medical devices / South Korea / Intromedic Co., Ltd
Intromedic Co., Ltd: FDA-registered device maker in Seoul, South Korea, 3 510(k) clearances
Intromedic Co., Ltd is registered with the FDA (registration 3007244127) in Seoul, 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
- 3007244127
- Address
- Suite 1105 1106 E&C Venture Dream Tower 6-Cha Guro Dong, Guro Gu, Seoul, South Korea, 152-719
- Owner or operator
- IntroMedic Co., Ltd. (10027343)
- Roles
- Complaint file establishment, Manufacturer
- 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, Manufacturer | 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.