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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