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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
Correspondent 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)
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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