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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 K983219
Device Name NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
Applicant
DRAGER, INC.
3136 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact HARALD KNEUER
Correspondent
DRAGER, INC.
3136 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact HARALD KNEUER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/14/1998
Decision Date 12/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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