Electrophysiology device developer EP MedSystems has received Food and Drug Administration market clearance for its EP-4 computerized cardiac stimulator.
The product is a touch-screen portable PC controlling a two- or four-channel dedicated electrophysiology (EP) stimulator. The stimulator is capable of single-channel, simultaneous, and sequential stimulation at programmed output settings.
The EP-4’s four-channel constant-current output provides increased versatility for site pacing and emergency backup and is compatible with the majority of the industry’s EP recording systems, according to the West Berlin, NJ-based firm.
EP MedSystems also has received regulatory approval from its European Notified Body for the EP-4, allowing the sale of the EP-4 into the European Community, the company said.
By AuntMinnie.com staff writersMarch 4, 2004
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