FDA 510(k) Application Details - K192604

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K192604
Device Name	Ventilator, Continuous, Facility Use
Applicant	Maquet Critica Care AB R÷ntgenvΣgen 2 Solna 17154 SE Other 510(k) Applications for this Company
Contact	David Ardanius 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	09/20/2019
Decision Date	06/18/2020
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