Data / Medical devices / China / GMC Inc.
GMC Inc.: FDA-registered device maker in Chuzhou Anhui, China, 2 510(k) clearances
GMC Inc. is registered with the FDA (registration 3015531743) in Chuzhou Anhui, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 4, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015531743
- Address
- No.686 Su Chu RD, Chuzhou Anhui, China, 239000
- Owner or operator
- GMC Inc. (10060729)
- Roles
- Manufacturer
- First device listed
- July 1, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | 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 |
|---|---|---|---|---|---|---|
| April 4, 2019 | K181931 | GMC Upper Arm Automatic Blood Pressure Monitor | DXN | Substantially Equivalent | Gmc, Inc. | accessdata.fda.gov |
| February 14, 2019 | K181930 | GMC Wrist Automatic Blood Pressure Monitor | DXN | Substantially Equivalent | Gmc, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 4, 2019. 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.