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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conditioner, signal, physiological
510(K) Number K060919
Device Name ACTICAL
Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville,  PA  15668
Contact zita a yurko
Regulation Number882.1845
Classification Product Code
GWK  
Date Received04/04/2006
Decision Date 09/22/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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