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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 K875118
Device Name PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
Applicant
Bloodflow Laboratory, Inc.
4400 Diana Dr.
Broadview Heights,  OH  44147
Applicant Contact PINE, MD
Correspondent
Bloodflow Laboratory, Inc.
4400 Diana Dr.
Broadview Heights,  OH  44147
Correspondent Contact PINE, MD
Regulation Number870.2780
Classification Product Code
JOM  
Date Received12/15/1987
Decision Date 05/16/1988
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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