FDA 510(k) Application Details - K191270

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K191270
Device Name	Nebulizer (Direct Patient Interface)
Applicant	PARI Respiratory Equipment, Inc. 2412 PARI Way Midlothian, VA 23112 US Other 510(k) Applications for this Company
Contact	Michael Judge 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	05/13/2019
Decision Date	01/23/2020
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