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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
Applicant
RESPIRONICS, INC.
1501 ardmore blvd.
pittsburgh,  PA  15221 -4401
Applicant Contact paul woodring
Correspondent
RESPIRONICS, INC.
1501 ardmore blvd.
pittsburgh,  PA  15221 -4401
Correspodent Contact paul woodring
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/24/1998
Decision Date 11/12/1998
Decision (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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