Sentrysuite Product Line

Q: What is the product code of K111053?

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

FDA 510(k) K111053 · Carefusion Germany 234 GmbH

Substantially Equivalent

510(k) numberK111053

Submission

Device name: Sentrysuite Product Line
Applicant: Carefusion Germany 234 GmbH
Hoechberg, DE
Received: April 15, 2011
Decision date: August 12, 2011
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)	Device	Applicant	Decision
K260242	CPETWise PlatformBTY · Traditional	Medibyt , Ltd.	08/20/2026SE
K242809	Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional	Medical Graphics Corporation	10/17/2024SE
K223629	SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional	Eresearchtechnology GmbH	05/28/2024SE
K231561	Pulmonary Function Tester, Model: A9BTY · Traditional	Guangzhou Homesun Medical Technology Co., Ltd.	02/21/2024SE
K222982	Virtus Metabolic MonitorBTY · Traditional	Virtus Technology Aps	06/23/2023SE
K221030	Model 9100 PFT/DICOBTY · Traditional	Vitalograph Ireland, Ltd.	07/15/2022SE
K202754	MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTY · Traditional	Eresearchtechnology GmbH	01/28/2021SE
K190800	Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional	Cosmed Srl	02/06/2020SE
K181912	Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional	Medical Graphics Corporation	04/12/2019SE
K173937	SpiroSphereBTY · Traditional	Eresearchtechnology GmbH	02/15/2019SE

More from Eresearchtechnology GmbH

510(k)	Device	Decision
K153654	Sentry WEB SmartInterpDQK · Traditional	09/16/2016SE
K150810	Vyntus / SentrySuite Product LineBZC · Traditional	08/14/2015SE
K142959	Vyntus WalkDQA · Traditional	03/20/2015SE
K141936	Microblab, MicroloopBZG · Traditional	12/29/2014SE
K133925	Vyntus/ Sentrysuite Product LineBZC · Traditional	08/22/2014SE
K122699	Sentrysuite Product LineBTY · Traditional	11/19/2012SE
K113813	Sentrysuite Product LineBTY · Traditional	05/10/2012SE
K113096	Micro IBZG · Traditional	04/13/2012SE
K111408	Microgard IICAH · Traditional	10/17/2011SE
K101873	Masterscreen IosBZG · Traditional	02/10/2011SE

Questions and answers

When was Sentrysuite Product Line cleared by the FDA?

Sentrysuite Product Line (K111053) received a 510(k) decision of Substantially Equivalent on August 12, 2011, 119 days after the submission was received.

What is the product code of K111053?

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