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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, biofeedback
510(k) Number K922838
Device Name NORODYN 2000 ELECTROMYOGRAPH
Applicant
NOROMED, INC.
720 OLIVE WAY
SUITE 800
SEATTLE,  WA  98101
Applicant Contact ADIB
Correspondent
NOROMED, INC.
720 OLIVE WAY
SUITE 800
SEATTLE,  WA  98101
Correspondent Contact ADIB
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/12/1992
Decision Date 09/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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