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
121–139 of 139
Cleared May 16, 1985
RECOMED BLOOD-FLOW METER H236-052-02
K840522
Litton Medical Electronics
Cardiovascular · 464d
Cleared Mar 01, 1985
PHONOANGIOGRAPHIC SPECTRAL ANALYZER
K840169
Biotronics Instruments
Cardiovascular · 410d
Cleared Feb 20, 1985
PERIFLUX PF-2
K844631
Medex, Inc.
Cardiovascular · 85d
Cleared Jul 08, 1982
XOMED PATENCY MONITOR
K821373
Xomed, Inc.
Cardiovascular · 59d
Cleared Apr 15, 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742
Nihon Kohden America, Inc.
Cardiovascular · 28d
Cleared Mar 12, 1982
CLINIFLOW II, #701, ELECTROMAGN. BLD. SY
K820272
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Feb 04, 1982
CAPILLARY PERFUSION MONITOR #LD5000
K812005
Nuclear Pacific, Inc.
Cardiovascular · 205d
Cleared Aug 13, 1981
ULTRASONIC QFM SYSTEM 1000
K811376
Narco Bio-Systems
Cardiovascular · 90d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL BVM30
K811615
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL TS266
K811616
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246
Irex Corp.
Cardiovascular · 99d
Cleared Apr 10, 1981
DOPSCAN MODEL 1050
K810561
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Jan 02, 1981
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
K801802
Medical Testing System, Inc.
Cardiovascular · 157d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN CONTROL
K800151
Syva Co.
Toxicology · 14d
Cleared Oct 04, 1979
VASCULIZER
K791418
Diagnostics Intl.
Cardiovascular · 69d
Cleared Apr 21, 1978
BLOOD FLOWMETER SYSTEM
K780302
Medtronic Vascular
Cardiovascular · 58d
Cleared Feb 01, 1977
ARTERIAL DIAGNOSTIC UNIT (ADU)
K770115
Medical Electronic Devices, Inc.
Cardiovascular · 13d
Cleared Dec 28, 1976
P-1 ULTRASONIC ARTERIOGRAPH
K761288
D. Eugene Hokanson
Cardiovascular · 8d
Cleared Oct 13, 1976
CONTINUOUS WAVE DOPPLER
K760751
Medsonics
Cardiovascular · 12d