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FDA 510(k)

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

K-Number: K202754 · 2021-01-28

ApplicantEresearchtechnology GmbH
Decision Date2021-01-28
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is a medical device manufactured by Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2021-01-28 under approval number K202754. 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 MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Eresearchtechnology GmbH. The 510(k) number is K202754.

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

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU received FDA 510(k) clearance on 2021-01-28, under approval number K202754.

What company makes MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is manufactured by Eresearchtechnology GmbH.

What is the FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

The FDA product code for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU is BTY.

Other Devices by Eresearchtechnology GmbH

K173937SpiroSphere K223629SpiroSphere, SpiroSphereECG, CardioSphere

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Official Source

View on FDA Database →

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

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