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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medium-Term Adjunctive Predictive Cardiovascular Indicator
510(k) Number K233253
Device Name eCARTv5 Clinical Deterioration Suite (“eCART”)
Applicant
Agilemd, Inc.
2261 Market St. #4378
San Francisco,  CA  94114
Applicant Contact Borna Safabakhsh
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann H. Payne
Regulation Number870.2210
Classification Product Code
QNL  
Date Received09/28/2023
Decision Date 06/21/2024
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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