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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K861260
Device Name PEDABAROGRAPH
Applicant
Biokinetics, Inc.
806 Fifteenth St., NW
Suite 228
Washington,  DC  20005
Applicant Contact MICHAEL O JARRETT
Correspondent
Biokinetics, Inc.
806 Fifteenth St., NW
Suite 228
Washington,  DC  20005
Correspondent Contact MICHAEL O JARRETT
Regulation Number890.1600
Classification Product Code
JFC  
Date Received04/03/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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