FDA 510(k) Applications Submitted by Allison Scott

FDA 510(k) Number Submission Date Device Name Applicant
K110238 01/26/2011 G-SCAN ESAOTE S.P.A.
K110262 01/28/2011 SHARPS CONTAINER NOBLE MARKETING
K110511 02/23/2011 E4D COMPASS D4D TECHNOLOGIES
K190447 02/25/2019 7400 Ultrasound Systems Navigant Consulting - on behalf of Esaote S.p.A.
K100670 03/09/2010 S-SCAN, MODEL 9800020010 ESAOTE, S.P.A.
K110688 03/11/2011 MYLABGOLD ESAOTE
K140677 03/18/2014 MYLABSSOGNO ESAOTE S.P.A.
K110802 03/23/2011 A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 ESAOTE S.P.A.
K100931 04/05/2010 MYLABTWICE, MODEL 6200 ESAOTE, S.P.A.
K091009 04/09/2009 MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 ESAOTE S.P.A.
K111302 05/09/2011 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A.
K081386 05/19/2008 MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) ESAOTE S.P.A.
K121650 06/05/2012 S-SCAN ESAOTE, S.P.A.
K141486 06/05/2014 MYLABSIX ULTRASOUND SYSTEM ESAOTE EUROPE B.V.
K101605 06/08/2010 MYLABONE ULTRASOUND SYSTEM ESAOTE EUROPE B.V.
K111765 06/23/2011 FULL CORE BIOPSY SYSTEM PROMEX TECHNOLOGIES, LLC
K111803 06/27/2011 G-SCAN ESAOTE, S.P.A.
K121996 07/09/2012 BE PLUS LTM AMPLIFIER GWI AMPLIFIER EB NEURO, S.P.A.
K132231 07/18/2013 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A.
K062039 07/19/2006 BIOPSY DIGIT-AM GIOTTO USA, LLC
K142008 07/23/2014 MYLABSEVEN, MYLABALPHA ESAOTE S.P.A.
K122205 07/25/2012 EXINI EXINI DIAGNOSTICS AB
K071996 07/26/2007 MYLAB30, MODEL 7300 ESAOTE S.P.A.
K142077 07/31/2014 MYLABGAMMA ESAOTE, S.P.A.
K062261 08/04/2006 FOAM RING PORT PROTECTOR INSPIRED IDEAS, INCORPORATED
K132466 08/07/2013 MYLABSEVEN 6400, MYLABALPHA 7400 ESAOTE S.P.A.
K092469 08/11/2009 O-SCAN MR SYSTEM ESAOTE S.P.A.
K062544 08/30/2006 AR1000 ULTRASONIC WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC
K062735 09/13/2006 TUTU 7, MODEL IV-T22 INVISIBLE TECHNOLOGY CO., LTD.
K092973 09/25/2009 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE BIONEN S.A.S.
K103152 10/26/2010 6250 ULTRASOUND SYTEMS ESAOTE, S.P.A.
K073415 12/04/2007 NEMUS SYSTEM; NEMUS PC PERIPHERAL EB NEURO, S.P.A.
K133905 12/23/2013 6200 / 6250 ULTRASOUND SYSTEM ESAOTE S.P.A.
K120288 01/31/2012 ORTHOCAD SOFTWARE OPTION ESAOTE, S.P.A.
K120748 03/12/2012 SPEEDUP SOFTWARE OPTION ESAOTE, S.P.A.
K140701 03/20/2014 NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG NOVOSOURCE INC
K121384 05/08/2012 MYLABSOGNO ESAOTE, S.P.A.
K131996 06/28/2013 S-SCAN ESAOTE, S.P.A.
K122006 07/09/2012 G-SCAN BRIO ESAOTE, S.P.A.
K142064 07/30/2014 GALILEO NT EB NEURO, S.P.A.
K132386 08/01/2013 TOTALSHIELD SURGICAL HELMET SYSTEM ZIMMER, INC.
K122443 08/10/2012 UFIT TEN-10 BIOSIGN TECHNOLOGIES, INC.
K133517 11/15/2013 NEMUS 2 SYSTEM EB NEURO, S.P.A.
K123553 11/19/2012 ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM ZIMMER INC.


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