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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 K903089
Device Name BABYLOG 8000 INFANT VENTILATOR
Applicant
DRAGER, INC.
101 TECHNOLOGY DR.
P.O. BOX 120
PITTSBURGH,  PA  15230
Applicant Contact STEFAN FREMBGEN
Correspondent
DRAGER, INC.
101 TECHNOLOGY DR.
P.O. BOX 120
PITTSBURGH,  PA  15230
Correspondent Contact STEFAN FREMBGEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/13/1990
Decision Date 06/10/1991
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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