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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 K111595
Device Name NEUMOVENT GRAPHNET
Applicant
Tecme S.A.
79 Brookline Rd.
Mason,  NH  03048
Applicant Contact Ray Kelly
Correspondent
Tecme S.A.
79 Brookline Rd.
Mason,  NH  03048
Correspondent Contact Ray Kelly
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/07/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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