FDA 510(k) Application Details - K221634

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K221634
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	Magnamed Tecnologia Medica S/A 801/831, Rua Santa Monica Cotia 06715-865 BR Other 510(k) Applications for this Company
Contact	Toru Kinjo Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2022
Decision Date	05/24/2023
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