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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 K874415
Device Name PRESSURE LIMIT CONTROL
Applicant
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Applicant Contact D DOUGHERTY
Correspondent
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact D DOUGHERTY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/28/1987
Decision Date 01/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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