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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 K860271
Device Name BIOFEEDBACK MICROLAB
Applicant
Hrm Software/Div. of Human Relations Media
175 Tompkins Ave.
Pleasantville,  NY  10570
Applicant Contact PETER COCHRAN
Correspondent
Hrm Software/Div. of Human Relations Media
175 Tompkins Ave.
Pleasantville,  NY  10570
Correspondent Contact PETER COCHRAN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received01/27/1986
Decision Date 06/18/1986
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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