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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 K875179
Device Name MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
Applicant
Tsi, Inc.
500 Cardigan Rd.
P.O. Box 64394
St. Paul,  MN  55112
Applicant Contact HAUMSCHILD, PHD
Correspondent
Tsi, Inc.
500 Cardigan Rd.
P.O. Box 64394
St. Paul,  MN  55112
Correspondent Contact HAUMSCHILD, PHD
Regulation Number870.2100
Classification Product Code
DPW  
Date Received12/17/1987
Decision Date 09/19/1988
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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