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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 K951486
Device Name MODEL PV2000 VASCULAR MICROLABORATORY
Applicant
Vasamedics, LLC
2963 Yorkton Blvd.
Saint Paul,  MN  55117
Applicant Contact JOHN BORGOS
Correspondent
Vasamedics, LLC
2963 Yorkton Blvd.
Saint Paul,  MN  55117
Correspondent Contact JOHN BORGOS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/30/1995
Decision Date 06/29/1995
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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