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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
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