FDA 510(k) Application Details - K202219

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K202219
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 US Other 510(k) Applications for this Company
Contact	Adam Palumbo 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	08/06/2020
Decision Date	02/11/2021
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