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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 Street,
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
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