FDA 510(k) Application Details - K251352

Device Classification Name	Gas-Machine, Anesthesia   More FDA Info for this Device
510(K) Number	K251352
Device Name	Gas-Machine, Anesthesia
Applicant	Codonics.Incorporated 17991 Englewood Drive Middleburg Heights, OH 44130 US Other 510(k) Applications for this Company
Contact	Gary Enos Other 510(k) Applications for this Contact
Regulation Number	868.5160   More FDA Info for this Regulation Number
Classification Product Code	BSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2025
Decision Date	07/11/2025
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