FDA 510(k) Applications for Medical Device Product Code "DPT"
(Probe, Blood-Flow, Extravascular)

FDA 510(k) Number Applicant Device Name Decision Date
K121429 AIMAGO SA AIMAGO EASYLDI MICROCIRCULATION CAMERA 08/10/2012
K123216 AIMAGO SA AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN 02/07/2013
K052989 DELTEX MEDICAL DP240 240 HOUR DOPPLER PROBE 03/08/2006
K142932 DELTEX MEDICAL LIMITED Deltex Medical KDP72 Doppler Probe 01/22/2015
K073593 DELTEX MEDICAL LIMITED I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 01/29/2009
K963703 INTERNATIONAL BIOPHYSICS CORP. ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) 04/08/1998
K013939 JOSTRA AG JOSTRA FLOWPROBE FP-32E 12/14/2001
K132730 MEDTRONIC INC. BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE 05/30/2014
K133903 MEDTRONIC INC. BIO-PROBE TRANSDUCER (ADULT) 04/10/2014
K012747 MEDTRONIC PERFUSION SYSTEMS TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) 09/14/2001
K152749 Moor Instruments Ltd moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager 05/12/2016
K980383 MOOR INSTRUMENTS LTD. MOOORLDI LASER DOPPLER IMAGER 04/30/1998
K063586 MOOR INSTRUMENTS LTD. MOORFLPI FULL-FIELD LASER PERFUSION IMAGER 01/25/2007
K122943 MOOR INSTRUMENTS LTD. MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER 01/03/2013
K060976 MOOR INSTRUMENTS LTD. MOORLD12-B1 LASER DOPPLER BURNS IMAGER 03/27/2007
K032841 MOOR INSTRUMENTS LTD. MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR 12/10/2003
K063561 MOOR INSTRUMENTS LTD. MOORLDLS LASER DOPPLER LINE SCANNER 01/19/2007
K132163 MOOR INSTRUMENTS LTD. MOORLDLS-BI LASER DOPPLER BURNS IMAGER 01/29/2014
K120884 PERIMED AB PERICAM PSI 07/03/2012
K124049 Spectral MD, Inc DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM 04/18/2013
K163339 SPECTRALMD, INC. SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 08/17/2017
K951832 VASAMEDICS, L.L.C. LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 03/21/1996
K961368 VASAMEDICS, L.L.C. TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT 10/11/1996
K962700 VASAMEDICS, L.L.C. VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT 04/09/1997


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