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FDA 510(k) Application Details - K222982
Device Classification Name
Calculator, Predicted Values, Pulmonary Function
More FDA Info for this Device
510(K) Number
K222982
Device Name
Calculator, Predicted Values, Pulmonary Function
Applicant
Virtus Technology ApS
Svalevej 4
Roennede DK-4683 DK
Other 510(k) Applications for this Company
Contact
Leif Olesen
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
09/28/2022
Decision Date
06/23/2023
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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