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510(k) K181524

Device
Vyntus ONE With CART, Vyntus ONE PFT Only With CART, Vyntus ONE With Adjustable CART, Vyntus ONE PFT Only With Adjustable CART
Applicant
Vyaire Medical, Inc.
510(k) number
K181524
Product code
BZC  
Decision
Substantially Equivalent (SESE)
Decision date
2018-11-30
Date received
2018-06-11
Regulation
868.1880
Classification name
Calculator, Pulmonary Function Data
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Elmar Niedermeyer
Address
Leibnizstrasse 7 Hoechber DE 97204 97204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240293STSTechbopulm, Ltd.2024-09-17
K183567Vyntus/SentrySuite Product LineVyaire Medical2019-08-23
K190853Vyntus BODYVyaire Medical, Inc.2019-08-16
K162515COSMED K5 Wearable Metabolic TechnologyCosmed Srl2017-06-20
K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.2016-10-21
K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH2015-08-14
K133925VYNTUS/ SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2014-08-22
K133051PULMONE MINIBOX PFT TMPulmone Advanced Medical Devices, Ltd.2014-05-02
K102047LCI OPTION FOR INNOCORInnovision A/S2011-11-01
K072323MASTERSCREEN & OXYCON CPXViasys Healthcare GmbH2007-10-10
K052328ZAN LUNG-FUNCTION LABZan Messgerate GmbH2005-12-22
K040698MASTERSCREEN CPX AND OXYCON CPXViasys Healthcare GmbH2004-04-07
K023120OXYCON MOBILEErich Jaeger GmbH2003-11-12
K011344INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400Collins Medical, Inc.2002-05-17
K001631CORTEX METAMAXCortex Biophysik GmbH2001-02-22

Legacy Summary#

summary

FDA Review#

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