FDA 510(k) Application Details - K230987

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K230987
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	Baldus Sedation GmbH & Co. KG In der Langfuhr 32 Bendorf 56170 DE Other 510(k) Applications for this Company
Contact	Lisa Baldus 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	04/06/2023
Decision Date	09/14/2023
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