510(k) K250002— Smart Check O2 (MA0236)

Substantially Equivalent

Life Spark Medical, LLC

Clearance details

Applicant: Life Spark Medical, LLC
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2025-01-02
Decision date: 2025-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, UT, US

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.