FDA 510(k) Application Details - K232523

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K232523
Device Name	Nebulizer (Direct Patient Interface)
Applicant	Mankind Pharma Limited 208, Okhla Industrial Estate Phase-3 New Delhi 110020 IN Other 510(k) Applications for this Company
Contact	Rajender Singh 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	08/18/2023
Decision Date	04/10/2024
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