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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K243270
Device Name TigerConnect Alarm Management
Applicant
Tigerconnect
2054 Broadway
Santa Monica,  CA  90404
Applicant Contact Steve Tyler
Correspondent
Speed TO Market, Inc.
P.O. Box 3018
Nederland,  CO  80466
Correspondent Contact Thomas Kroenke
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Code
PHC  
Date Received10/16/2024
Decision Date 09/30/2025
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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