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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K202456
Device Name M5 Recorder
Applicant
Global Instrumentation, LLC
8104 Cazenovia Rd.
Manlius,  NY  13104
Applicant Contact Jason DeMaso
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number870.2800
Classification Product Code
DSH  
Subsequent Product Code
DXH  
Date Received08/27/2020
Decision Date 12/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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