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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 K001488
Device Name NARKOMED MRI , NM-MRI
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact J TERESA DORREITY, JD
Correspondent
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact J TERESA DORREITY, JD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received05/12/2000
Decision Date 06/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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