Thermometer Kit
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Jiangsu, and 2 other provinces: 11 hold an FDA registration. 1 is a contract manufacturer.
- Dongguan Mars Medical Products Co., Ltd. Guangdong
- Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
- Guangdong Prestige Technology Co., Ltd. Guangdong
- Jinhua Ivy Home Textile Co., Limited Zhejiang, contract manufacturer
- Ningbo Just Soon Industrial Limited Zhejiang
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
- Shanghai FLY Medical Devices Co., Ltd. Shanghai
- Shanghai Link Instruments Co., Ltd. Jiangsu
- Shenzhen Changkun Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Xiazhifeng Electronic Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Zhongde Audio-Technical Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code PXH?
Thermometer Kit is FDA product code PXH, Class 2, 21 CFR 880.2910.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.