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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