Sentrysuite Product Line

FDA 510(k) K122699 · Carefusion Germany 234 GmbH

Substantially Equivalent

510(k) numberK122699

Submission

Device name
Sentrysuite Product Line
Applicant
Carefusion Germany 234 GmbH
Hoechberg, DE
Received
September 4, 2012
Decision date
November 19, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTY – Calculator, Predicted Values, Pulmonary Function
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1890
Specialty
Anesthesiology

Other 510(k)s with product code BTY

510(k)DeviceApplicantDecision
K260242CPETWise PlatformBTY · Traditional Medibyt , Ltd.08/20/2026SE
K242809Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional Medical Graphics Corporation10/17/2024SE
K223629SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional Eresearchtechnology GmbH05/28/2024SE
K231561Pulmonary Function Tester, Model: A9BTY · Traditional Guangzhou Homesun Medical Technology Co., Ltd.02/21/2024SE
K222982Virtus Metabolic MonitorBTY · Traditional Virtus Technology Aps06/23/2023SE
K221030Model 9100 PFT/DICOBTY · Traditional Vitalograph Ireland, Ltd.07/15/2022SE
K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTY · Traditional Eresearchtechnology GmbH01/28/2021SE
K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional Cosmed Srl02/06/2020SE
K181912Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional Medical Graphics Corporation04/12/2019SE
K173937SpiroSphereBTY · Traditional Eresearchtechnology GmbH02/15/2019SE

More from Eresearchtechnology GmbH

510(k)DeviceDecision
K153654Sentry WEB SmartInterpDQK · Traditional 09/16/2016SE
K150810Vyntus / SentrySuite Product LineBZC · Traditional 08/14/2015SE
K142959Vyntus WalkDQA · Traditional 03/20/2015SE
K141936Microblab, MicroloopBZG · Traditional 12/29/2014SE
K133925Vyntus/ Sentrysuite Product LineBZC · Traditional 08/22/2014SE
K113813Sentrysuite Product LineBTY · Traditional 05/10/2012SE
K113096Micro IBZG · Traditional 04/13/2012SE
K111408Microgard IICAH · Traditional 10/17/2011SE
K111053Sentrysuite Product LineBTY · Traditional 08/12/2011SE
K101873Masterscreen IosBZG · Traditional 02/10/2011SE

Questions and answers

When was Sentrysuite Product Line cleared by the FDA?

Sentrysuite Product Line (K122699) received a 510(k) decision of Substantially Equivalent on November 19, 2012, 76 days after the submission was received.

What is the product code of K122699?

The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.