Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Siemens Shenzhen Magnetic Resonance Ltd. Guangdong, contract manufacturer
How Is MOH Classified?
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) is FDA product code MOH, Class 2, 21 CFR 884.2730.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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