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FDA 510(k) Application Details - K202754
Device Classification Name
Calculator, Predicted Values, Pulmonary Function
More FDA Info for this Device
510(K) Number
K202754
Device Name
Calculator, Predicted Values, Pulmonary Function
Applicant
eResearchTechnology GmbH
Sieboldstrasse 3
Estenfeld 97230 DE
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Contact
Margit Kohlen
Other 510(k) Applications for this Contact
Regulation Number
868.1890
More FDA Info for this Regulation Number
Classification Product Code
BTY
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More FDA Info for this Product Code
Date Received
09/21/2020
Decision Date
01/28/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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