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FDA 510(k) Applications Submitted by COLLEEN HITTLE DENSMORE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K020068
01/09/2002
SONOREAL 3D SYSTEM
BIO MEDI COM
K020112
01/11/2002
50S TRINGA ULTRASOUND IMAGING SYSTEM
PIE MEDICAL
K020164
01/17/2002
E-SCAN XQ
BIOSOUND ESAOTE, INC.
K040113
01/20/2004
SANDMAN SD20 AMPLIFIER
EB NEURO, S.P.A.
K030363
02/04/2003
ORG@NIZER, MODEL VERSION 3.0
EBIT SANITA, S.P.A.
K040399
02/17/2004
QONTRAST
AMID
K021495
05/09/2002
QIVA
PIE MEDICAL IMAGING B.V.
K023473
10/16/2002
SONOREAL 3D
BIO MEDI COM
K023512
10/21/2002
PICUS ULTRASOUND IMAGING SYSTEMS
PIE MEDICAL
K033604
11/17/2003
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
PIE MEDICAL
K014168
12/19/2001
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
BIOSOUND ESAOTE, INC.
K023255
09/30/2002
TECHNOS MP, MODEL AU6
BIOSOUND ESAOTE, INC.
K032121
07/09/2003
MODIFICATION TO E-SCAN XQ
ESAOTE S.P.A.
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