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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 K101401
Device Name NEUMOVENT GRAPHNET MODEL 3179L1V
Applicant
TECME S.A.
56B SHADOWBROOK DRIVE
HUDSON,  NH  03051
Applicant Contact RAYMOND KELLY
Correspondent
TECME S.A.
56B SHADOWBROOK DRIVE
HUDSON,  NH  03051
Correspondent Contact RAYMOND KELLY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/18/2010
Decision Date 12/07/2010
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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