510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name monitor, breathing frequency 510(k) Number K891486 Device Name AR-800PA RESPIRATION MODULE Applicant NIHON KOHDEN AMERICA, INC. 17112 armstrong ave. irvine,  CA  92714 Contact mike dashefsky Regulation Number 868.2375 Classification Product Code BZQ   Date Received 03/17/1989 Decision Date 10/24/1989 Decision substantially equivalent (SE) Classification Advisory Committee Anesthesiology Review Advisory Committee Anesthesiology Type Traditional Reviewed by Third Party No Expedited Review