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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 K900725
Device Name RADIO FREQUENCY RECEIVER SUBSYSTEM
Applicant
Myheal Technologies
140-05 Jewel Ave.
Flushing,  NY  11367
Applicant Contact ORBACH, PH.D.
Correspondent
Myheal Technologies
140-05 Jewel Ave.
Flushing,  NY  11367
Correspondent Contact ORBACH, PH.D.
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/15/1990
Decision Date 03/23/1990
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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