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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 the device name listed in this FDA 510(k) record. The listed applicant is Eresearchtechnology GmbH. It received FDA 510(k) clearance on 2021-01-28 under 510(k) 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. The listed applicant is Eresearchtechnology GmbH. The 510(k) number is K202754.

When did MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU receive FDA 510(k) clearance?

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

Who is the listed applicant for MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU?

The FDA 510(k) record lists Eresearchtechnology GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing Eresearchtechnology GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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