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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K101295
Device Name MROPEN
Applicant
PARAMED SRL
39 HIGH STREET
NORTH ANDOVER,  MA  01845
Applicant Contact RICHARD R GLASHEEN
Correspondent
PARAMED SRL
39 HIGH STREET
NORTH ANDOVER,  MA  01845
Correspondent Contact RICHARD R GLASHEEN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/10/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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