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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 K200337
Device Name FloPatch (FP120)
Applicant
Flosonics Medical (r/a 1929803 Ontario Corp.)
325 Front St W, Fourth Floor, OneEleven
toronto,  CA m5v 2y1
Applicant Contact andrew eibl
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/11/2020
Decision Date 03/24/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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