FDA 510(k) Application Details - K190800

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K190800
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	Cosmed Srl Vi dei Piani di Monte Savello 37, Albano Laziale Rome 0041 IT Other 510(k) Applications for this Company
Contact	Andrea Duca 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	03/28/2019
Decision Date	02/06/2020
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