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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 K050993
FOIA Releasable 510(k) K050993
Device Name MMS VIDEO OPTION
Applicant
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Applicant Contact KARIN OGINK-SOMHORST
Correspondent
Medical Measurement Systems B.V.
Colosseum 25
Enschede Overijssel,  NL 7521 PV
Correspondent Contact KARIN OGINK-SOMHORST
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/19/2005
Decision Date 05/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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