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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 K014058
Device Name ENTEGRA PE PERSONAL DIGITAL ASSISTANT
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact D. DUERSTELER
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact REINER KRUMME
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2001
Decision Date 12/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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