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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name recorder, event, implantable cardiac, (without arrhythmia detection)
510(k) Number K192593
Device Name Confirm Rx Insertable Cardiac Monitor
15900 Valley View Ct.
sylmar,  CA  91342
Applicant Contact laura sparks
15900 Valley View Ct.
sylmar,  CA  91342
Correspondent Contact laura sparks
Regulation Number870.2800
Classification Product Code
Subsequent Product Code
Date Received09/20/2019
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No