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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, facility use
510(k) Number K981072
Device Name ESPRIT VENTILATOR
Original Applicant
RESPIRONICS, INC.
1501 ardmore blvd.
pittsburgh,  PA  15221 4401
Original Contact paul woodring
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/24/1998
Decision Date 11/12/1998
Decision se subject to tracking reg (ST)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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