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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K093192
Device Name FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE
Applicant
Advanced Vascular Dynamics
1910 NW 23rd Pl.
Portland,  OR  97210
Applicant Contact HERBERT SEMLER
Correspondent
Advanced Vascular Dynamics
1910 NW 23rd Pl.
Portland,  OR  97210
Correspondent Contact HERBERT SEMLER
Regulation Number870.2780
Classification Product Code
JOM  
Date Received10/09/2009
Decision Date 02/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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