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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K860289
Device Name PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
Applicant
PROFESSIONAL HEALTH TECHNOLOGIES, INC.
915 CAMINO DEL MAR, STE 100
DEL MAR,  CA  92014
Applicant Contact THEODORE BENSON
Correspondent
PROFESSIONAL HEALTH TECHNOLOGIES, INC.
915 CAMINO DEL MAR, STE 100
DEL MAR,  CA  92014
Correspondent Contact THEODORE BENSON
Regulation Number882.1835
Classification Product Code
GWL  
Date Received01/28/1986
Decision Date 08/25/1986
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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