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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K253088
Device Name OneStim-DUO Cardiac Stimulator (MP5003-4CO)
Applicant
Micropace Pty, Ltd.
Unit 41, 159 Arthur St.
Homebush W.,  AU 2140
Applicant Contact Michael Cejnar
Correspondent
Acorn N Oakes, LLC
333 N. Dobson Rd. Vo5
Chandler,  AZ  85224
Correspondent Contact Amy Oakes
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
JOQ  
Date Received09/23/2025
Decision Date 06/12/2026
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		 Yes
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