FDA 510(k) Application Details - K191876

Device Classification Name	More FDA Info for this Device
510(K) Number	K191876
Device Name	PulmoScan
Applicant	Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana, CA 92701 US Other 510(k) Applications for this Company
Contact	Rajoshi Biswas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2019
Decision Date	03/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review