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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K141809
Device Name RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
Applicant
Defibtech, LLC
741 Boston Post Rd.
Guilford,  CT  06437
Applicant Contact Ed Horton
Correspondent
Defibtech, LLC
741 Boston Post Rd.
Guilford,  CT  06437
Correspondent Contact Ed Horton
Regulation Number870.5200
Classification Product Code
DRM  
Date Received07/07/2014
Decision Date 10/27/2014
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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