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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 K934538
Device Name MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY
Applicant
Noise Cancellation Technologies
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Noise Cancellation Technologies
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/20/1993
Decision Date 04/25/1994
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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