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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K871912
Device Name PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
Applicant
Electro-Diagnostic Instruments
3401 Winona Ave.
Burbank,  CA  91504
Applicant Contact ROBERT L SMITH
Correspondent
Electro-Diagnostic Instruments
3401 Winona Ave.
Burbank,  CA  91504
Correspondent Contact ROBERT L SMITH
Regulation Number870.2120
Classification Product Code
DPT  
Date Received05/18/1987
Decision Date 02/18/1988
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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