Data / Medical devices / China / Foshan Gaunying Electronics Co., Ltd
Foshan Gaunying Electronics Co., Ltd: FDA-registered device maker in Foshan Guangdong, China, 5 510(k) clearances
Foshan Gaunying Electronics Co., Ltd is registered with the FDA (registration 3008395118) in Foshan Guangdong, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 30, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008395118
- Address
- No. 501, 5th Floor, Building 5, No. 51, Jiang Hai Road Zhang Cha Street, Chan Cheng District, Foshan Guangdong, China, 528000
- Owner or operator
- Foshan Gaunying Electronics Co., LTD (10032493)
- Roles
- Manufacturer
- First device listed
- July 13, 2011
- Registered through
- 2026
- Brand names listed
- Gaunying Infrared Lamp FIR51, SN-51, Mesh Atomizer Model: NM212, NM232, Mesh Atomizer Model: NM222, Personal Inhaler, Model NM211A (NB30)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | 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 30, 2014 | K140211 | ULTRASONIC MESH NEBULIZER | CAF | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
| January 8, 2014 | K132247 | ULTRASONIC MESH NEBULIZER | CAF | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
| August 20, 2012 | K121154 | ULTRASONIC NEBULIZER | CAF | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
| March 30, 2011 | K110721 | GAUNYING INFRARED LAMP | ILY | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
| January 5, 2011 | K101693 | GAUNYING INFRARED LAMP MODEL IL50 | ILY | Substantially Equivalent | Foshan Gaunying Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
Updated May 30, 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.