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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 K864259
Device Name MODIFIED LASERFLO BLOOD PERFUSION MONITOR
Applicant
Tsi, Inc.
500 Cardigan Rd.
P.O. Box 64394
St. Paul,  MN  55112
Applicant Contact DAN HAUMSCHILD
Correspondent
Tsi, Inc.
500 Cardigan Rd.
P.O. Box 64394
St. Paul,  MN  55112
Correspondent Contact DAN HAUMSCHILD
Regulation Number870.2100
Classification Product Code
DPW  
Date Received10/29/1986
Decision Date 02/20/1987
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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