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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 K973537
Device Name PATHWAY ELECTROMYOGRAPH
Applicant
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Applicant Contact PETER A SULLIVAN
Correspondent
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Correspondent Contact PETER A SULLIVAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/18/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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