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
73–96 of 139
Cleared Dec 07, 1993
PERITEMP PF 4005 HEATER
K932068
Perimed, Inc.
Cardiovascular · 222d
Cleared Oct 12, 1993
P/METER
K921377
Zertl Medical, Inc.
Radiology · 567d
Cleared Sep 16, 1993
MS DISPOSABLE RIGID DOPPLER PROBE
K930227
Meadox Medicals, Div. Boston Scientific Corp.
Radiology · 240d
Cleared Aug 23, 1993
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)
K925524
Cardio Metrics, Inc.
Cardiovascular · 294d
Cleared May 18, 1993
LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER
K922034
Titronics Medical Instruments, Inc.
Radiology · 382d
Cleared Feb 03, 1993
PERIFLUX PF4001 LASER DOPPLER FLOWMETER
K922368
Perimed, Inc.
Cardiovascular · 259d
Cleared Jan 29, 1993
MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW
K922669
Koven and Assoc., Inc.
Cardiovascular · 239d
Cleared Jan 22, 1993
SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K920333
Koven and Assoc., Inc.
Cardiovascular · 361d
Cleared Dec 10, 1992
MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR
K915550
Koven and Assoc., Inc.
Radiology · 365d
Cleared Jul 21, 1992
PIM 1.0 LASER DOPPLER PERFUSION IMAGER
K920844
Lisca Development AB
Cardiovascular · 148d
Cleared Jan 09, 1992
ABCOM 2000
K912562
Applied Biometrics, Inc.
Radiology · 212d
Cleared Dec 12, 1991
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
K912446
Vasamedics, LLC
Cardiovascular · 192d
Cleared Nov 19, 1991
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827
Hewlett-Packard Co.
Radiology · 85d
Cleared Aug 13, 1991
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)
K911763
Vasamedics, LLC
Cardiovascular · 116d
Cleared Apr 29, 1991
INTERSPEC APOGEE, MODIFICATION
K910049
Interspec, Inc.
Cardiovascular · 112d
Cleared Mar 29, 1991
FLOWIRE AND FLOMAP
K905411
Cardio Metrics, Inc.
Cardiovascular · 116d
Cleared Feb 26, 1991
ES-1000SP II SMART DOP
K903026
Koven and Assoc., Inc.
Cardiovascular · 231d
Cleared Feb 13, 1991
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
K904317
Avalon Technology Corp.
Cardiovascular · 146d
Cleared Jan 28, 1991
DIAGNOSTIC ULTRASOUND VERSADOPP 1000
K904792
Diagnostic Ultrasound Corp.
Cardiovascular · 97d
Cleared Nov 07, 1990
DOPPLER NEEDLE AND FLOW MONITOR
K903625
Peripheral Systems Group
Cardiovascular · 89d
Cleared Nov 05, 1990
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
K901015
Wright Medical Corp.
Cardiovascular · 245d
Cleared Oct 09, 1990
ADVANCE LASER FLOWMETER, ALF 21
K903633
Transonic Systems, Inc.
Cardiovascular · 60d
Cleared Aug 10, 1990
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335
Ge Medical Systems Information Technologies
Cardiovascular · 141d
Cleared Aug 08, 1990
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088
Hewlett-Packard Co.
Cardiovascular · 90d