MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Calculator, Predicted Values, Pulmonary Function

EResearchTechnology GmbH

The following data is part of a premarket notification filed by Eresearchtechnology Gmbh with the FDA for Masterscope, Masterscope Ct, Masterscope Ecg, Masterscope Wssu.

Pre-market Notification Details

Device IDK202754
510k NumberK202754
Device Name:MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant eResearchTechnology GmbH Sieboldstrasse 3 Estenfeld,  DE 97230
ContactMargit Kohlen
CorrespondentMargit Kohlen
eResearchTechnology GmbH Sieboldstrasse 3 Estenfeld,  DE 97230
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-01-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000566 K202754 000
04057155000641 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000566 K202754 000
04057155000641 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000
04057155000566 K202754 000
04057155000634 K202754 000
04057155000641 K202754 000

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