Data / Medical devices / China / DM Systems (beijing) Co., Ltd.
DM Systems (beijing) Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
DM Systems (beijing) Co., Ltd. is registered with the FDA (registration 3008413470) in Beijing, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 19, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008413470
- Address
- Room 1102, No. 2 Bldg, No. 10 Baifuquan Changping District, Beijing, 102200, Beijing, China, 102200
- Owner or operator
- DM Systems (Beijing) Co., Ltd. (10032719)
- Roles
- Manufacturer
- First device listed
- June 11, 2010
- Registered through
- 2026
- Brand names listed
- Holter ECG recorder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 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 |
|---|---|---|---|---|---|---|
| May 19, 2014 | K133014 | DMS 300-2W HOLTER ECG RECORDER | MWJ | Substantially Equivalent | Diagnostic Monitoring Software | accessdata.fda.gov |
| October 16, 2006 | K062959 | DMS 300-2, 300-3 AND 300-4 | MWJ | Substantially Equivalent | Diagnostic Monitoring Software | accessdata.fda.gov |
Compare with other makers
Updated May 19, 2014. 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.