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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K935832
Device Name CHROMOPHARE
Applicant
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Applicant Contact W HILL
Correspondent
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Correspondent Contact W HILL
Regulation Number880.6320
Classification Product Code
KZF  
Date Received12/07/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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