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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K250002
Device Name Smart Check O2 (MA0236)
Applicant
Life Spark Medical, LLC
2430 W 350 N
Washington,  UT  84737
Applicant Contact Darryl Zitting
Correspondent
Life Spark Medical, LLC
2430 W 350 N
Washington,  UT  84737
Correspondent Contact Darryl Zitting
Regulation Number868.1720
Classification Product Code
CCL  
Date Received01/02/2025
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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