FDA 510(k) Applications for Medical Device Product Code: BTY (Calculator, Predicted Values, Pulmonary Function)

FDA 510(k) Applications for Medical Device Product Code "BTY"
(Calculator, Predicted Values, Pulmonary Function)

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

FDA 510(k) Applications for Medical Device Product Code "BTY" (Calculator, Predicted Values, Pulmonary Function)

FDA 510(k) Applications for Medical Device Product Code "BTY"
(Calculator, Predicted Values, Pulmonary Function)