FDA 510(k) Application Details - K250002

Device Classification Name	Analyzer, Gas, Oxygen, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K250002
Device Name	Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant	Life Spark Medical, LLC 2430 W 350 N Washington, UT 84737 US Other 510(k) Applications for this Company
Contact	Darryl Zitting Other 510(k) Applications for this Contact
Regulation Number	868.1720   More FDA Info for this Regulation Number
Classification Product Code	CCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2025
Decision Date	04/24/2025
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