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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 K211289
Device Name RMU-2000 Automated Chest Compression System
Applicant
Defibtech, LLC
741 Boston Post Road
Guilford,  CT  06437
Applicant Contact Allison Bohren
Correspondent
Defibtech, LLC
741 Boston Post Road
Guilford,  CT  06437
Correspondent Contact Allison Bohren
Regulation Number870.5200
Classification Product Code
DRM  
Date Received04/28/2021
Decision Date 11/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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