Home / Device Classification / BTY

BTY — Calculator, Predicted Values, Pulmonary Function Class II

FDA Device Classification

Classification Details

Product Code
BTY
Device Class
Class II
Regulation Number
868.1890
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242809medical graphics corporationAscent Cardiorespiratory Diagnostic SoftwareOctober 17, 2024
K223629eresearchtechnologySpiroSphere, SpiroSphereECG, CardioSphereMay 28, 2024
K231561guangzhou homesun medical technology coPulmonary Function Tester, Model: A9February 21, 2024
K222982virtus technology apsVirtus Metabolic MonitorJune 23, 2023
K221030vitalograph irelandModel 9100 PFT/DICOJuly 15, 2022
K202754eresearchtechnologyMasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUJanuary 28, 2021
K190800cosmedCosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsFebruary 6, 2020
K181912medical graphics corporationAscent Cardiorespiratory Diagnostic SoftwareApril 12, 2019
K173937eresearchtechnologySpiroSphereFebruary 15, 2019
K161534ndd medizintechnikEasyOne Pro Respiratory Analysis SystemFebruary 22, 2017
K150888shape medical systemsShape-HF Cardiopulmonary Testing SystemJanuary 21, 2016
K122699carefusion germany 234SENTRYSUITE PRODUCT LINENovember 19, 2012
K120635ndd medizitechnikEASYONE PRO RESPIRATORY TESTING DEVICESeptember 27, 2012
K113813carefusion germany 234SENTRYSUITE PRODUCT LINEMay 10, 2012
K111053carefusion germany 234SENTRYSUITE PRODUCT LINEAugust 12, 2011
K091428ndd medizitechnikEASYONE PRO RESPIRATORY ANALYSIS SYSTEMJanuary 27, 2010
K090722shape medical systemsSHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEMMarch 31, 2009
K082539cardinal health germany 234MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CTDecember 2, 2008
K080510viasys healthcareVIP PULMONARY FUNCTION SYSTEMAugust 20, 2008
K080734viasys healthcareFLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTJune 26, 2008