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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(K) Number K122857
Model HOPE-11310, HEART-100609, THERAMIST-31000N
Device Name HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
Applicant
PEGASUS RESEARCH CORP.
3303 harbo blvd
suite f3
costa mesa,  CA  92626
Contact kenneth miller
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/18/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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