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Enteral Device Articles & Analysis
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U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has ...
Each kit from RemetricHealth includes a customizable selection of biometric devices, including a scale, blood pressure monitor, pulse oximeter, and spirometer. The devices operate via Bluetooth and automatically upload data via the included Samsung 4G tablet straight to a HIPAA-compliant web portal for physicians, with zero technology lift on the part of the ...
The company’s proprietary VisionPort™ system combines four instruments into one and is being developed as a disposable device. It enters as a trocar, functions as a laparoscope and deploys as a camera and an instrument channel. ...
Designed for operating environments with varying levels of communications infrastructure, vrMIS allows data to be entered and reported through a convenient and intuitive web interface when Internet connectivity is available. For greater versatility, data can also be uploaded via SMS and smartphone devices or entered and stored offline when ...