FDA 510(k) Application Details - K181912

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K181912
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	Medical Graphics Corporation 350 Oak Grove Parkway Saint Paul, MN 55127-8599 US Other 510(k) Applications for this Company
Contact	Jim McGurran Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	BTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2018
Decision Date	04/12/2019
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	Y
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