BTY · Calculator, Predicted Values, Pulmonary Function

Anesthesiology · 21 CFR 868.1890 · Class 2

Overview

Product CodeBTY
Device NameCalculator, Predicted Values, Pulmonary Function
Regulation21 CFR 868.1890
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 63)

Showing 20 most recent of 63 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationOct 17, 2024SESE
K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHMay 28, 2024SESE
K231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.Feb 21, 2024SESE
K222982Virtus Metabolic MonitorVirtus Technology ApsJun 23, 2023SESE
K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.Jul 15, 2022SESE
K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbHJan 28, 2021SESE
K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed SrlFeb 6, 2020SESE
K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationApr 12, 2019SESE
K173937SpiroSphereEresearchtechnology GmbHFeb 15, 2019SESE
K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AGFeb 22, 2017SESE
K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc.Jan 21, 2016SESE
K122699SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbHNov 19, 2012SESE
K120635EASYONE PRO RESPIRATORY TESTING DEVICENdd Medizitechnik AGSep 27, 2012SESE
K113813SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbHMay 10, 2012SESE
K111053SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbHAug 12, 2011SESE
K091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEMNdd Medizitechnik AGJan 27, 2010SESE
K090722SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEMShape Medical Systems, Inc.Mar 31, 2009SESE
K082539MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CTCardinal Health Germany 234 GmbHDec 2, 2008SESE
K080510VIP PULMONARY FUNCTION SYSTEMViasys Healthcare GmbHAug 20, 2008SESE
K080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTViasys Healthcare GmbHJun 26, 2008SESE

Top Applicants

Innolitics

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