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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K040931
Device Name PATXFER RT
Applicant
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Applicant Contact RAINER BIRKENBACH
Correspondent
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Correspondent Contact RAINER BIRKENBACH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2004
Decision Date 07/22/2004
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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