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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K222330
Device Name The Heart Seat
Applicant
Casana Care, Inc.
150 Metro Park, Suite A
Rochester,  NY  14623
Applicant Contact Kara Johnson
Correspondent
Biologics Consulting
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQA  
Date Received08/02/2022
Decision Date 04/24/2023
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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