FDA 510(k) Application Details - K183586

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K183586
Device Name	Nebulizer (Direct Patient Interface)
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	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	09/13/2019
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	N
Expedited Review