MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Q: What is the product code of K202754?

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) K202754 · Eresearchtechnology GmbH

Substantially Equivalent

510(k) numberK202754

Submission

Device name: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
Applicant: Eresearchtechnology GmbH
Estenfeld, DE
Received: September 21, 2020
Decision date: January 28, 2021
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
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
K161534	EasyOne Pro Respiratory Analysis SystemBTY · Traditional	Ndd Medizintechnik AG	02/22/2017SE

More from Ndd Medizintechnik AG

510(k)	Device	Decision
K223629	SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional	05/28/2024SE
K173937	SpiroSphereBTY · Traditional	02/15/2019SE

Questions and answers

When was MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU cleared by the FDA?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (K202754) received a 510(k) decision of Substantially Equivalent on January 28, 2021, 129 days after the submission was received.

What is the product code of K202754?

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