FDA 510(k) Applications Submitted by SHELLY HARRIS

FDA 510(k) Number Submission Date Device Name Applicant
K110028 01/05/2011 MASIMO RADICAL Y PULSE CO-OXIMETER MASIMO CORPORATION
K110723 03/16/2011 M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS MASIMO CORPORATION
K160979 04/07/2016 Inclusive Abutments PRISMATIK DENTALCRAFT, INC.
K131249 05/01/2013 ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-FLOW LLC
K181436 06/01/2018 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test Sekisui Diagnostics, LLC
K182001 07/26/2018 Acucy Influenza A&B Test with the Acucy System Sekisui Diagnostics, LLC


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