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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 K182494
Device Name FlowMet-R
Applicant
Laser Associated Sciences, Inc.
16 Foxglove Way
Irvine,  CA  92612
Applicant Contact Sean White
Correspondent
Laser Associated Sciences, Inc.
16 Foxglove Way
Irvine,  CA  92612
Correspondent Contact Sean White
Regulation Number870.2100
Classification Product Code
DPW  
Date Received09/11/2018
Decision Date 02/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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