Data / Medical devices / China / Shenzhen Changke Connect Electronics Co., Ltd.
Shenzhen Changke Connect Electronics Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances
Shenzhen Changke Connect Electronics Co., Ltd. is registered with the FDA (registration 3017619536) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017619536
- Address
- A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street Longgang District, Shenzhen Guangdong, China, 518115
- Owner or operator
- Shenzhen Changke Connect Electronics Co., Ltd. (10078314)
- Roles
- Manufacturer
- First device listed
- October 18, 2020
- Registered through
- 2026
- Brand names listed
- Cable,Snap Connector,Disposable,120IN, 35m (Model: P01-001-00572), Cable,Snap Connector,Disposable,72IN, 1.83m (Model: P01-001-00570), Cable,Snap Connector,Disposable,96IN, 2.44m (Model: P01-001-00571), Disposable ECG Cable (model: CK-SMD-12C4-03A6), Disposable EEG electrode (P01-001-00566; EEG electrode, Disp, 48IN, set of 10), Disposable EEG electrode (P01-001-00567; EEG electrode, Disp, 72IN, set of 14), Disposable EEG electrode (P01-001-00568; EEG electrode, Disp, 96IN, set of 14), Disposable EEG electrode (P01-001-00569; EEG electrode, Disp, 120IN, set of 14) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 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 6, 2022 | K213884 | Disposable EEG cable | GXY | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
| July 24, 2020 | K193625 | Disposable Temperature Probe | FLL | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
| May 12, 2020 | K200026 | Disposable ECG Cable | DSA | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
| March 25, 2020 | K193629 | Disposable NIBP Cuff | DXQ | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
| November 27, 2019 | K191428 | ECG Cable | DSA | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
| September 17, 2019 | K191253 | Reusable NIBP Cuff | DXQ | Substantially Equivalent | Shenzhen Changke Connect Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Blood Pressure Cuff
- All makers of Cable, Electrode
- All makers of Continuous Measurement Thermometer
Updated May 6, 2022. 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.