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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 K897132
Device Name PATHWAY II ELECTROMYOGRAPH
Applicant
The Prometheus Group
80 Bow St.
Portsmouth,  NH  03801
Applicant Contact RICHARD W POORE
Correspondent
The Prometheus Group
80 Bow St.
Portsmouth,  NH  03801
Correspondent Contact RICHARD W POORE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received12/27/1989
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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