FDA 510(k) Applications Submitted by Mara Caler

FDA 510(k) Number Submission Date Device Name Applicant
K110212 01/25/2011 INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
K060817 03/27/2006 OMNILINK. 018 BILIARY STENT SYSTEM GUIDANT ENDOVASCULAR SOLUTIONS, INC.
K190878 04/04/2019 Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff Salter Labs, Inc.
K071212 05/01/2007 ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC.
K051122 05/02/2005 ITAG MHC TETRAMER CMV ASSAY BECKMAN COULTER, INC.
K151421 05/28/2015 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines Salter Labs
K151506 06/04/2015 Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula Salter Labs
K161719 06/22/2016 Salter Labs Bubble Humidifier SALTER LABS
K151874 07/09/2015 BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal Salter Labs
K012900 08/29/2001 ACCESS UNCONJUGATED ESTRIOL CALIBRATORS BECKMAN COULTER, INC.
K072450 08/31/2007 ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC.
K082660 09/12/2008 V60 VENTILATOR, MODEL V8000 RESPIRONICS CALIFORNIA, INC.
K002905 09/18/2000 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER BECKMAN COULTER, INC.
K093032 09/29/2009 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET BIOSITE INCORPORATED
K003098 10/03/2000 ACCESS ULTRASENSITIVE HGH CALIBRATORS BECKMAN COULTER, INC.
K023597 10/28/2002 ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC.
K994277 12/20/1999 ACCESS OSTASE QC BECKMAN COULTER, INC.


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