FDA 510(k) Application Details - K193191

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K193191
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	Weinmann Emergency Medical Technology GmbH + Co. KG Frohb÷sestra▀e 12 Hamburg 22525 DE Other 510(k) Applications for this Company
Contact	Kristin Ratschiller 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	11/19/2019
Decision Date	11/20/2020
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