Itamar Medical, Framingham, Ma, announced today that the US Food and Drug Administration accepted the premarket 510(k) notification for the Watch-PAT200. The Watch-PAT200 will offer sleep specialists, and other physicians managing sleep related breathing disorders, with the technology to diagnose and evaluate patients with obstructive sleep apnea.
The Watch-PAT200 is less than half the size of its predecessor, the Watch-PAT100. The Watch-PAT200 provides clinical data including apnea-hypopnea index, oxygen desaturation levels, sleep time and sleep phases, including REM, without requiring a nasal canula or EEG electrodes.
The Watch-PAT200 was presented at the Itamar-Medical booth at the Annual Meeting of the Associated Professional Sleep Societies in Baltimore and will be available for purchase starting August 2008.