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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K860651
Device Name MICRON, MICROVASCULAR DOPPLER
Applicant
Diagnostic Electronics Corp.
Box 580
Lexington,  MA  02173
Applicant Contact BARBARA M WILLIAMS
Correspondent
Diagnostic Electronics Corp.
Box 580
Lexington,  MA  02173
Correspondent Contact BARBARA M WILLIAMS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/21/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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