FDA 510(k) Application Details - K250322

Device Classification Name	Conserver, Oxygen   More FDA Info for this Device
510(K) Number	K250322
Device Name	Conserver, Oxygen
Applicant	Responsive Respiratory 6244 Lemay Ferry Rd St. Louis, MO 63129 US Other 510(k) Applications for this Company
Contact	Steve Bannon Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2025
Decision Date	07/24/2025
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