Cleared Traditional

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

K202754 · Eresearchtechnology GmbH · Anesthesiology

Jan 2021

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K202754 is an FDA 510(k) clearance for the MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Eresearchtechnology GmbH (Estenfeld, DE). The FDA issued a Cleared decision on January 28, 2021, 129 days after receiving the submission on September 21, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K202754 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2020
Decision Date	January 28, 2021
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF