Vyntus/SentrySuite Product Line

Q: What is the product code of K183567?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.

FDA 510(k) K183567 · Vyaire Medical

Substantially Equivalent

510(k) numberK183567

Submission

Device name: Vyntus/SentrySuite Product Line
Applicant: Vyaire Medical
Hoechber, DE
Received: December 21, 2018
Decision date: August 23, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: BZC – Calculator, Pulmonary Function Data
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.1880
Specialty: Anesthesiology

Other 510(k)s with product code BZC

510(k)	Device	Applicant	Decision
K240293	STSBZC · Traditional	Techbopulm, Ltd.	09/17/2024SE
K190853	Vyntus BODYBZC · Traditional	Vyaire Medical, Inc.	08/16/2019SE
K181524	Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional	Vyaire Medical, Inc.	11/30/2018SE
K162515	COSMED K5 Wearable Metabolic TechnologyBZC · Traditional	Cosmed Srl	06/20/2017SE
K161295	MiniBox +BZC · Traditional	Pulmone Advanced Medical Devices, Ltd.	10/21/2016SE
K150810	Vyntus / SentrySuite Product LineBZC · Traditional	Carefusion Germany 234 GmbH	08/14/2015SE
K133925	Vyntus/ Sentrysuite Product LineBZC · Traditional	Carefusion Germany 234 GmbH	08/22/2014SE
K133051	Pulmone Minibox PFT TMBZC · Traditional	Pulmone Advanced Medical Devices, Ltd.	05/02/2014SE
K102047	Lci Option for InnocorBZC · Traditional	Innovision A/S	11/01/2011SE
K072323	Masterscreen & Oxycon CPXBZC · Special	Viasys Healthcare GmbH	10/10/2007SE

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K200510	Multi-LinkTM X2 ECG Adapter and LeadwiresDSA · Traditional	10/09/2020SE
K191273	Multi-Link X2 ECG and SpO2 AdapterDSA · Traditional	09/13/2019SE
K190853	Vyntus BODYBZC · Traditional	08/16/2019SE
K181524	Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional	11/30/2018SE
K171678	Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas…CCK · Traditional	04/30/2018SE
K170378	AirLife Adult Heated Wire BiPAP/NIV CircuitBZE · Traditional	09/14/2017SE

Questions and answers

When was Vyntus/SentrySuite Product Line cleared by the FDA?

Vyntus/SentrySuite Product Line (K183567) received a 510(k) decision of Substantially Equivalent on August 23, 2019, 245 days after the submission was received.

What is the product code of K183567?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.