DSB · Class II · 21 CFR 870.2770

FDA Product Code DSB: Plethysmograph, Impedance

Leading manufacturers include Cardiodynamics International Corp., ImpediMed Limited and Bomed Medical Mfr., Ltd..

115
Total
115
Cleared
188d
Avg days
1977
Since
115 devices
25–48 of 115
Cleared Jun 18, 2009
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
K080941
N.I. Medical, Ltd.
Cardiovascular · 441d
Cleared May 28, 2009
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
K090602
Cardiodynamics International Corp.
Cardiovascular · 84d
Cleared Dec 15, 2008
CHEETAH RELIANT
K083093
Cheetah Medical, Inc.
Cardiovascular · 59d
Cleared Oct 08, 2008
ICON, MODEL C3
K082242
Osypka Medical, Inc.
Cardiovascular · 62d
Cleared May 30, 2008
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
K081035
Osypka Medical, Inc.
Cardiovascular · 49d
Cleared Apr 10, 2008
PHYSIOFLOW SYSTEM
K060387
Vasocom, Inc.
Cardiovascular · 786d
Cleared Feb 01, 2008
AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
K070985
Osypka Medical, Inc.
Cardiovascular · 301d
Cleared Jan 16, 2008
CHEETAH RELIANT, CHEETAH ACTIVE
K072662
Cheetah Medical, Inc.
Cardiovascular · 117d
Cleared Sep 26, 2007
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156
Cardiodynamics International Corp.
Cardiovascular · 252d
Cleared Jul 16, 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500
Ni Medical
Cardiovascular · 145d
Cleared Jun 10, 2005
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
K051228
Cardiodynamics International Corp.
Cardiovascular · 28d
Cleared Dec 08, 2004
BIOZDX HEMODYNAMIC MONITOR
K041294
Cardiodynamics International Corp.
Cardiovascular · 208d
Cleared Sep 14, 2004
ZOE FLUID STATUS MONITOR
K042113
Noninvasive Medical Technologies, LLC
Cardiovascular · 40d
Cleared Aug 06, 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434
Analogic Corp.
Cardiovascular · 70d
Cleared Sep 04, 2003
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
K032491
Imagyn Medical Technologies, Inc.
Cardiovascular · 23d
Cleared Apr 29, 2003
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174
Imagyn Surgical
Cardiovascular · 382d
Cleared Feb 07, 2002
TASK FORCE MONITOR 3040
K014063
Cnsystems Medizintechnik GmbH
Cardiovascular · 58d
Cleared Jan 30, 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299
Sorba Medical Systems, Inc.
Cardiovascular · 30d
Cleared Nov 02, 2001
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439
Cardiodynamics International Corp.
Cardiovascular · 176d
Cleared Jul 03, 2001
BIOZTECT SENSOR AND BIOZTECT CABLE
K011797
Cardiodynamics International Corp.
Cardiovascular · 25d
Cleared Apr 09, 2001
ICG MODULE
K010164
General Electric Medical Systems Information Techn
Cardiovascular · 81d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081
Cardiodynamics International Corp.
Cardiovascular · 87d
Cleared May 05, 2000
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
K001100
Cardiodynamics International Corp.
Cardiovascular · 30d
Cleared Feb 08, 1999
IQ SYSTEM
K981720
Renaissance Technology, Inc.
Cardiovascular · 279d