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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 K883648
Device Name BETA 3000M MOBILE NMR IMAGING SYSTEM
Applicant
Fonar Corp.
110 Marcus Dr.
Melville,  NY  11747
Applicant Contact JOHN D HAYTAIAN
Correspondent
Fonar Corp.
110 Marcus Dr.
Melville,  NY  11747
Correspondent Contact JOHN D HAYTAIAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/30/1988
Decision Date 10/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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