Data / Medical devices / China / Fudakang Industrial Co Ltd
Fudakang Industrial Co Ltd: FDA-registered device maker in Dongguan Guangdong, China, 6 510(k) clearances
Fudakang Industrial Co Ltd is registered with the FDA (registration 3008167616) in Dongguan Guangdong, China. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 7, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008167616
- Address
- 501, Building 2, No. 11 Changheng Road, Changping Town, Dongguan Guangdong, China, 523560
- Owner or operator
- Fudakang Industrial Co Ltd (10031413)
- Roles
- Manufacturer
- First device listed
- August 16, 2010
- Registered through
- 2026
- Brand names listed
- ADVOCATE: FT-F31 (ASPT-01), Banner Health Digital Thermometer: BHTRA01 (BT-A11CN), Blue Jay Arm & Wrist BPM:FT-C06(BJ120108), Clinical Electronic Thermometer FDK: BT-A11CN, BT-A41CN, Easy@Home Digital Basal Thermometer: EBT-100, EMT-A12, Easy@Home Smart Basal Thermometer: EBT-300, FDK ARM CUFF BLOOD PRESSURE MONITOR: FT-C15B, FDK ARM CUFF BPM W/NO VOICE: FT-C22Y and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| June 7, 2018 | K172121 | Digital Thermometer | FLL | Substantially Equivalent | Fudakang Industrial Co., Ltd. | accessdata.fda.gov |
| July 15, 2016 | K160308 | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | FLL | Substantially Equivalent | Fudakang Industrial Co., Ltd. | accessdata.fda.gov |
| March 28, 2016 | K152640 | Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
| April 17, 2015 | K150430 | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | Fudakang Industrial Co., Ltd. | accessdata.fda.gov |
| March 29, 2012 | K111703 | INFRARED EAR THEROMETER | FLL | Substantially Equivalent | Fudakang Industrial Co., Ltd. | accessdata.fda.gov |
| August 3, 2010 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Clinical Electronic Thermometer
Updated June 7, 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.