FDA 510(k) Application Details - K213564

Device Classification Name	Device, Positive Pressure Breathing, Intermittent   More FDA Info for this Device
510(K) Number	K213564
Device Name	Device, Positive Pressure Breathing, Intermittent
Applicant	ABMRC LLC 860 Blue Gentian Road Suite 200 Eagan, MN 55121 US Other 510(k) Applications for this Company
Contact	Leah Noaeill Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2021
Decision Date	12/21/2022
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