FDA 510(k) Applications Submitted by ROBERT TU

FDA 510(k) Number Submission Date Device Name Applicant
K110716 03/15/2011 EVERYWAY LOW BACK PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K161349 05/16/2016 Everyway Incontinence Stimulation System EVERYWAY MEDICAL INSTRUMENT CO., LTD.
K151479 06/02/2015 EV-820 OTC Pain Relief TENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K122194 07/24/2012 LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K012463 08/01/2001 LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K112415 08/22/2011 LIFECARE ARM & LEG PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K142794 09/29/2014 Everyway Facial MENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K180041 01/05/2018 BioCode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc.
K190585 03/06/2019 Biocode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc.
K192485 09/10/2019 BioCode Respiratory Pathogen Panel (RPP) Applied BioCode, Inc.
K960920 03/06/1996 CLINIX MP PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K980918 03/11/1998 JPACS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K010817 03/19/2001 MX8000 V5.0 CT SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K001088 04/04/2000 ULTRASIM CT SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K060937 04/05/2006 BRILLIANCE VOLUME PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K962010 05/23/1996 EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K982010 06/08/1998 FACTS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K012009 06/27/2001 MX8000 IDT CT SYSTEM MARCONI MEDICAL SYSTEMS, INC.
K002005 07/03/2000 BOLUSPRO ULTRA MARCONI MEDICAL SYSTEMS, INC.
K042293 08/24/2004 BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K033326 10/16/2003 PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM PHILIPS MEDICAL SYSTEMS, INC.
K013644 11/05/2001 ACQPLAN 5.0 PHILIPS MEDICAL SYSTEMS, INC.
K023785 11/12/2002 LUNG NODULE ASSESSMENT AND COMPARISON OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K955268 11/17/1995 PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K033677 11/24/2003 BRAIN PERFUSION OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K974513 12/01/1997 PINPOINT PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K974770 12/22/1997 ACQPLAN PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K970227 01/17/1997 IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER DPC CIRRUS
K980855 03/05/1998 IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT DPC CIRRUS
K021208 04/16/2002 IMMULITE 2000 MIXED ALLERGEN PANELS DIAGNOSTIC PRODUCTS CORP.
K021206 04/16/2002 IMMULITE 2000 SPECIFIC ALLERGENS DIAGNOSTIC PRODUCTS CORP.
K974842 12/24/1997 IMMULITE 2000 3RD GENERATION PSA DIAGNOSTIC PRODUCTS CORP.
K972095 06/04/1997 IMMULITE 2000 PSA DIAGNOSTIC PRODUCTS CORP.


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