FDA 510(k) Application Details - K231895

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K231895
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	Maxtec, LLC 2305 South 1070 West Salt Lake City, UT 84119 US Other 510(k) Applications for this Company
Contact	Sidra Hankins 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	06/28/2023
Decision Date	12/04/2023
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