Viatom gets FDA 510(k) clearance for Checkme vitals monitoring device

by MedGadget

The Checkme Pro portable health monitor from Viatom Technology, a company out of Shenzhen, China, has been 510(k) cleared by the FDA. The device performs one-lead ECG recording, pulse oximetry, temperature measurement, and movement sensing. There’s also cuffless systolic blood pressure measurement that relies on calibration, but this part has not been included in the U.S. version.

The ECG is capable of providing QRS duration, ST segment, and rhythm analysis for basic cardiac monitoring of patients, while the pulse oximeter can do up to 10 hours of SpO2 tracking while the patient wears the device to sleep.

The device is meant for quick health evaluations that can be performed easily, even by the patient, and reviewed by a physician as necessary back at the clinic.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History from a web browser, so either mobile devices or computers can be used to quickly find your primary predicate, multiple predicates or reference devices to build a successful 510(k) clearance strategy. Save money in your 510(k) regulatory strategy and follow-on 510(k) submission spend by enabling self-service extraction of actionable insight from more than 62,000 FDA medical device 510(k) clearance summaries, plus more than 76,000 splash pages for a total of nearly 139,000 records.