FDA 510(k) Application Details - K220591

Device Classification Name	Conserver, Oxygen   More FDA Info for this Device
510(K) Number	K220591
Device Name	Conserver, Oxygen
Applicant	Dynasthetics LLC 3487 West 2100 South #300 Salt Lake City, UT 84119 US Other 510(k) Applications for this Company
Contact	Joseph Orr 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	03/01/2022
Decision Date	12/15/2022
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