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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
Predetermined Change
Control Plan Authorized		 No
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