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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K800223
Device Name PATIENT POSITIONING SYSTEM 1D OR 2D
Applicant
Laboratoire National D'Essais
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Laboratoire National D'Essais
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5780
Classification Product Code
IWE  
Date Received02/04/1980
Decision Date 03/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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