Can I read Biobeat BB-613WP FDA Approval Notice on EtoBox?

Biobeat BB-613WP FDA Approval Notice by ChatchayMahatano is a document available to read on EtoBox.

What is Biobeat BB-613WP FDA Approval Notice about?

The document describes a 510(k) premarket notification from Biobeat Technologies Ltd. for its Biobeat Platform and BB-613WP Patch. The device is intended to remotely monitor physiological data such as blood pressure, pulse oximetry, respiration rate, and temperature in healthcare and home settings to aid diagnosis and treatment, but not for critical care patients. The FDA determined the device to be substantially equivalent to legally marketed predicates.

Author

ChatchayMahatano

Language

EN