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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 K222242
Device Name FloPatch FP120
Applicant
Flosonics Medical
325 Front St W, Floor 4
Toronto,  CA M5V 2Y1
Applicant Contact Caleb Chin
Correspondent
Flosonics Medical
325 Front St W, Floor 4
Toronto,  CA M5V 2Y1
Correspondent Contact Caleb Chin
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/26/2022
Decision Date 12/09/2022
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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