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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K152778
Device Name TRACOE Cuff Pressure Monitor
Applicant
TRACOE MEDICAL GMBH
REICHELSHEIMER STR. 1/3
NIEDER-OLM,  DE D-55268
Applicant Contact STEPHAN KOHLER
Correspondent
AJW TECHNOLOGY CONSULTANTS, INC.
Reichelsheimer Str. 1/3
Nieder-Olm,  DE D-55268
Correspondent Contact Eva Schaeffer
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/25/2015
Decision Date 12/21/2016
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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