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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 K994117
Device Name MR ENHANCER
Applicant
I.Z.I. CORP.
P.O. BOX 4321
CROFTON,  MD  21114
Applicant Contact E. J SMITH
Correspondent
I.Z.I. CORP.
P.O. BOX 4321
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/06/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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