FDA 510(k)

SpiroSphere

K-Number: K173937 · 2019-02-15

Decision Date2019-02-15

Product CodeBTY

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SpiroSphere is a medical device manufactured by Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2019-02-15 under approval number K173937. 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?

SpiroSphere is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Eresearchtechnology GmbH. The 510(k) number is K173937.

When was SpiroSphere approved by the FDA?

SpiroSphere received FDA 510(k) clearance on 2019-02-15, under approval number K173937.

What company makes SpiroSphere?

SpiroSphere is manufactured by Eresearchtechnology GmbH.

What is the FDA product code for SpiroSphere?

The FDA product code for SpiroSphere is BTY.

Other Devices by Eresearchtechnology GmbH

K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU K223629SpiroSphere, SpiroSphereECG, CardioSphere

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 K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

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.