FDA 510(k) Application Details - K180779

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K180779
Device Name	Ventilator, Continuous, Facility Use
Applicant	Dragerwerk AG & CO. KGaA Moislinger Allee 53-55 Lubeck 23558 DE Other 510(k) Applications for this Company
Contact	Dr. Bettina Mobius Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2018
Decision Date	01/17/2019
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