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510(k) K150888

Device
Shape-HF Cardiopulmonary Testing System
Applicant
SHAPE MEDICAL SYSTEMS, INC
510(k) number
K150888
Product code
BTY  
Decision
Substantially Equivalent (SESE)
Decision date
2016-01-21
Date received
2015-04-02
Regulation
868.1890
Classification name
Calculator, Predicted Values, Pulmonary Function
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BERNARD HORWATH
Address
5000 Township Pkwy. St. Paul MN US 55110 55110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation2024-10-17
K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH2024-05-28
K231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.2024-02-21
K222982Virtus Metabolic MonitorVirtus Technology Aps2023-06-23
K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.2022-07-15
K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH2021-01-28
K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl2020-02-06
K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation2019-04-12
K173937SpiroSphereEresearchtechnology GmbH2019-02-15
K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG2017-02-22
K122699SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2012-11-19
K120635EASYONE PRO RESPIRATORY TESTING DEVICENdd Medizitechnik AG2012-09-27
K113813SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2012-05-10
K111053SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2011-08-12
K091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEMNdd Medizitechnik AG2010-01-27

Legacy Summary#

summary

FDA Review#

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