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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K092845
Device Name RESPISENS
Applicant
Nomics
Liege Science Park
4 Rue Des Chasseurs Ardennais
Angleur, Liege,  BE 4031
Applicant Contact PIERRE ANSAY
Correspondent
Nomics
Liege Science Park
4 Rue Des Chasseurs Ardennais
Angleur, Liege,  BE 4031
Correspondent Contact PIERRE ANSAY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/15/2009
Decision Date 01/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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