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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223290
Device Name CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
Applicant
SentiAR, Inc.
212 N Kingshighway Blvd., Suite 115 Mailbox 28
St. Louis,  MO  63108
Applicant Contact Alexander Schreiner
Correspondent
SentiAR, Inc.
212 N Kingshighway Blvd., Suite 115 Mailbox 28
St. Louis,  MO  63108
Correspondent Contact Alexander Schreiner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/26/2022
Decision Date 07/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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