FDA 510(k) Application Details - K221494

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K221494
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	DEHAS Medical Systems GmbH Wesloer Strabe 112 Luebeck 23568 DE Other 510(k) Applications for this Company
Contact	Jens Mittendorf Other 510(k) Applications for this Contact
Regulation Number	868.5330   More FDA Info for this Regulation Number
Classification Product Code	BZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2022
Decision Date	01/23/2023
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