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FDA 510(k)

Smart Check O2 (MA0236)

K-Number: K250002 · 2025-04-24

ApplicantLife Spark Medical, LLC
Decision Date2025-04-24
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Smart Check O2 (MA0236) is a medical device manufactured by Life Spark Medical, LLC. It received FDA 510(k) clearance on 2025-04-24 under approval number K250002. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Check O2 (MA0236)?

Smart Check O2 (MA0236) is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Life Spark Medical, LLC. The 510(k) number is K250002.

When was Smart Check O2 (MA0236) approved by the FDA?

Smart Check O2 (MA0236) received FDA 510(k) clearance on 2025-04-24, under approval number K250002.

What company makes Smart Check O2 (MA0236)?

Smart Check O2 (MA0236) is manufactured by Life Spark Medical, LLC.

What is the FDA product code for Smart Check O2 (MA0236)?

The FDA product code for Smart Check O2 (MA0236) is CCL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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