DPW · Class II · 21 CFR 870.2100

FDA Product Code DPW: Flowmeter, Blood, Cardiovascular

Leading manufacturers include Koven Technology, Inc., Transonic Systems, Inc. and Koven and Assoc., Inc..

139
Total
139
Cleared
165d
Avg days
1976
Since
139 devices
97–120 of 139
Cleared Jul 16, 1990
MODIFIED FLOCATH PULMONARY ARTERY CATHETER
K901733
Cardio Metrics, Inc.
Cardiovascular · 90d
Cleared Feb 16, 1990
FLAT VASCULAR PROBE
K896613
Imex Medical Systems, Inc.
Cardiovascular · 87d
Cleared Feb 13, 1990
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2
K896515
Tsi, Inc.
Cardiovascular · 90d
Cleared Jan 19, 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631
Nihon Kohden America, Inc.
Cardiovascular · 179d
Cleared Jul 28, 1989
DVM-4200 BLOOD FLOWMETER
K892707
Koven and Assoc., Inc.
Cardiovascular · 105d
Cleared Jun 20, 1989
PERIFLUX PF3
K890828
Perimed, Inc.
Cardiovascular · 119d
Cleared Nov 07, 1988
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
K882138
Imex Medical Systems, Inc.
Cardiovascular · 171d
Cleared Sep 19, 1988
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
K875179
Tsi, Inc.
Cardiovascular · 277d
Cleared Aug 29, 1988
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593
Cardio Metrics, Inc.
Cardiovascular · 66d
Cleared Jun 21, 1988
TRANSONIC FLOWMETER
K872048
Transonic Systems, Inc.
Cardiovascular · 390d
Cleared Feb 05, 1988
LAWRENCE L3000 CARDIAC OUTPUT MONITOR
K874885
Lawrence Medical Systems, Inc.
Cardiovascular · 66d
Cleared Dec 07, 1987
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490
Ge Medical Systems Information Technologies
Cardiovascular · 237d
Cleared Sep 30, 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068
Advanced Technology Laboratories, Inc.
Cardiovascular · 124d
Cleared Feb 20, 1987
MODIFIED LASERFLO BLOOD PERFUSION MONITOR
K864259
Tsi, Inc.
Cardiovascular · 114d
Cleared Jan 05, 1987
METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME
K853952
Metriflow, Inc.
Radiology · 467d
Cleared Nov 26, 1986
VELCOM-100
K863210
Waters Instruments, Inc.
Cardiovascular · 98d
Cleared Nov 17, 1986
DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER
K861023
Diagnostic Electronics Corp.
Cardiovascular · 244d
Cleared Nov 17, 1986
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720
Sonicaid, Inc.
Cardiovascular · 123d
Cleared Nov 10, 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841
Biosound, Inc.
Cardiovascular · 104d
Cleared Jul 29, 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766
Millar Instruments, Inc.
Cardiovascular · 148d
Cleared Jul 18, 1986
MICRON, MICROVASCULAR DOPPLER
K860651
Diagnostic Electronics Corp.
Cardiovascular · 147d
Cleared Feb 26, 1986
HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
K854500
Medpacific Corp.
Cardiovascular · 106d
Cleared Aug 14, 1985
TECA TC2-64 TRANSCRANIAL DOPPLER
K850137
Teca, Inc.
Cardiovascular · 212d
Cleared Jun 24, 1985
LASERFLO BLOOD PERFUSION MONITOR 403
K851057
Tsi, Inc.
Cardiovascular · 102d