FDA 510(k) Application Details - K231064

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K231064
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	SMD Manufacturing LLC 918 S 500 W, Ste A Salt Lake City, UT 84101 US Other 510(k) Applications for this Company
Contact	Jared Spendlove Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2023
Decision Date	07/13/2023
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