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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(With Arrhythmia Detection Or Alarms)
510(k) Number K252840
Device Name M12 Telemetry System
Applicant
Global Instrumentation, LLC
7010 Fly Rd. Suite 5
East Syracuse,  NY  13057
Applicant Contact Craig Sellers
Correspondent
Global Instrumentation, LLC
7010 Fly Rd. Suite 5
East Syracuse,  NY  13057
Correspondent Contact Doug Linquest
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/05/2025
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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