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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K202754
Device Name MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
Applicant
Eresearchtechnology GmbH
Sieboldstrasse 3
Estenfeld,  DE 97230
Applicant Contact Margit Kohlen
Correspondent
Eresearchtechnology GmbH
Sieboldstrasse 3
Estenfeld,  DE 97230
Correspondent Contact Margit Kohlen
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received09/21/2020
Decision Date 01/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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