Adjunctive Predictive Cardiovascular Indicator
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is It?
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
What Is FDA Product Code QAQ?
Adjunctive Predictive Cardiovascular Indicator is FDA product code QAQ, Class 2, 21 CFR 870.2210.
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.