FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K082539 |
CARDINAL HEALTH GERMANY 234 GMBH |
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT |
12/02/2008 |
K113813 |
CAREFUSION GERMANY 234 GMBH |
SENTRYSUITE PRODUCT LINE |
05/10/2012 |
K122699 |
CAREFUSION GERMANY 234 GMBH |
SENTRYSUITE PRODUCT LINE |
11/19/2012 |
K111053 |
CAREFUSION GERMANY 234 GMBH |
SENTRYSUITE PRODUCT LINE |
08/12/2011 |
K993641 |
CORTEX BIOPHYSIK GMBH |
METALYZER, MODEL 2; METALYZER, MODEL 3 |
12/14/2000 |
K020745 |
COSMED S.R.L. |
COSMED MICROQUARK |
01/02/2003 |
K040549 |
COSMED S.R.L. |
COSMED PONY FX |
09/28/2004 |
K190800 |
Cosmed Srl |
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors |
02/06/2020 |
K202754 |
eResearchTechnology GmbH |
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU |
01/28/2021 |
K173937 |
eResearchTechnology GmbH |
SpiroSphere |
02/15/2019 |
K980094 |
ERICH JAEGER B.V. |
MODIFICATION TO THE OXYCONALPHA |
07/28/1998 |
K000648 |
ERICH JAEGER GMBH |
SPIRO PRO |
03/29/2000 |
K961252 |
INAIR LTD. |
DSXL DIFFUSION SPIROMETER |
02/14/1997 |
K181912 |
Medical Graphics Corporation |
Ascent Cardiorespiratory Diagnostic Software |
04/12/2019 |
K161534 |
NDD MEDIZINTECHNIK AG |
EasyOne Pro Respiratory Analysis System |
02/22/2017 |
K091428 |
NDD MEDIZITECHNIK AG |
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM |
01/27/2010 |
K120635 |
NDD MEDIZITECHNIK AG |
EASYONE PRO RESPIRATORY TESTING DEVICE |
09/27/2012 |
K981366 |
SENSORMEDICS CORP. |
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES |
10/30/1998 |
K090722 |
SHAPE MEDICAL SYSTEMS, INC |
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM |
03/31/2009 |
K150888 |
SHAPE MEDICAL SYSTEMS, INC |
Shape-HF Cardiopulmonary Testing System |
01/21/2016 |
K080734 |
VIASYS HEALTHCARE GMBH |
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT |
06/26/2008 |
K071753 |
VIASYS HEALTHCARE GMBH |
MASTERSCREEN PNEUMO & MASTERSCOPE |
08/14/2007 |
K062011 |
VIASYS HEALTHCARE GMBH |
MODIFICATION TO FLOWSCREEN |
05/11/2007 |
K031194 |
VIASYS HEALTHCARE GMBH |
SPIROSOFT |
07/30/2003 |
K080510 |
VIASYS HEALTHCARE GMBH |
VIP PULMONARY FUNCTION SYSTEM |
08/20/2008 |
K222982 |
Virtus Technology ApS |
Virtus Metabolic Monitor |
06/23/2023 |
K221030 |
Vitalograph Ireland Ltd. |
Model 9100 PFT/DICO |
07/15/2022 |