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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K172216
Device Name ACIST RXi Mini System
Applicant
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact Amber Luker
Correspondent
Acist Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact Amber Luker
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received07/24/2017
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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