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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K971425
Device Name NARKOMED M ANESTHESIA SYSTEM (M)
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNON
Correspondent
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JAMES J BRENNON
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received04/17/1997
Decision Date 09/10/1997
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
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