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FDA 510(k)

SpiroSphere, SpiroSphereECG, CardioSphere

K-Number: K223629 · 2024-05-28

ApplicantEresearchtechnology GmbH
Decision Date2024-05-28
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SpiroSphere, SpiroSphereECG, CardioSphere is a medical device manufactured by Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2024-05-28 under approval number K223629. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpiroSphere, SpiroSphereECG, CardioSphere?

SpiroSphere, SpiroSphereECG, CardioSphere is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Eresearchtechnology GmbH. The 510(k) number is K223629.

When was SpiroSphere, SpiroSphereECG, CardioSphere approved by the FDA?

SpiroSphere, SpiroSphereECG, CardioSphere received FDA 510(k) clearance on 2024-05-28, under approval number K223629.

What company makes SpiroSphere, SpiroSphereECG, CardioSphere?

SpiroSphere, SpiroSphereECG, CardioSphere is manufactured by Eresearchtechnology GmbH.

What is the FDA product code for SpiroSphere, SpiroSphereECG, CardioSphere?

The FDA product code for SpiroSphere, SpiroSphereECG, CardioSphere is BTY.

Other Devices by Eresearchtechnology GmbH

K173937SpiroSphere K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Related Devices (Code: BTY)

K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation K173937SpiroSphereEresearchtechnology GmbH K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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