June 2015

SomnoMed Receives FDA 510(k) Clearance for SomnoDent Devices with Wearable Complicance Micro-Recording

 
by Finance News Network
 
SomnoMed Limited (ASX: SOM:AX) announced today that it had received FDA 510(k) clearance to commercialize their wearable SomnoDent devices fitted with DentiTrac® Micro-Recorders. SomnoMed is the first and only company in the world...

kBLASTER update June 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from May 2015 and FDA 510(k) splash pages for 510(k)s clearances in June 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  

With more than 60,000 510(k)...

FDA grants 510(k) clearance for Breathe Technologies Life2000 mechanical ventilation system

by Healio Pulmonology

Breathe Technologies has received 510(k) clearance from the US Food and Drug Administration for a mechanical ventilation system, according to a company press release.

The Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilator support for the care of adult patients who require ...

Cohero Health gets FDA 510(k) clearance for smartphone-connected spirometer

New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer. The Bluetooth-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History to ...