H2o

K974587 is the FDA 510(k) clearance record for H2O, a class II device, cleared for Grass-Telefactor Product Group on 1998-03-09 under FDA product code OLV (Standard Polysomnograph With Electroencephalograph). FDA's definition for product code OLV reads: "Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review...". FDA records list 12 510(k) clearances for Grass-Telefactor Product Group, from 1986-03-27 to 1999-08-06. As of 2026-09-10, FDA records show no recalls naming K974587.