FDA 510(k) Application Details - K250671

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K250671
Device Name	Generator, Oxygen, Portable
Applicant	CAIRE Inc. 2200 Airport Industrial Drive, Ste 500 Ball Ground, GA 30107 US Other 510(k) Applications for this Company
Contact	Ted Vlahopoulos Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2025
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