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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 K974176
Device Name BABYLOG 8000 PLUS
Applicant
Drager, Inc.
3136 Quarry Rd.
Telford,  PA  18969
Applicant Contact HARALD KNEUEAR
Correspondent
Drager, Inc.
3136 Quarry Rd.
Telford,  PA  18969
Correspondent Contact HARALD KNEUEAR
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/06/1997
Decision Date 06/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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