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510(k) K240293

Device
STS
Applicant
Techbopulm, Ltd.
510(k) number
K240293
Product code
BZC
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-17
Date received
2024-02-01
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
Shabtay Negry
Address
6 Ovadya St. Yad Benyamin IL

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
K183567Vyntus/SentrySuite Product LineVyaire Medical2019-08-23
K190853Vyntus BODYVyaire Medical, Inc.2019-08-16
K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.2018-11-30
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