FDA 510(k) Application Details - K242717

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K242717
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	Laboratorios Biogalenic, S.A. DE C.V. Calle Claper, Blvd. Del Ejercito Nacional km 5.5, Soyapango San Salvador 1639 SV Other 510(k) Applications for this Company
Contact	Roberto Qui±onez Other 510(k) Applications for this Contact
Regulation Number	868.5450   More FDA Info for this Regulation Number
Classification Product Code	BTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2024
Decision Date	01/30/2025
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