Smart Check O2 (MA0236)— 510(k) K250002
Substantially EquivalentLife Spark Medical, LLC
FDA 510(k) clearance K250002 for Smart Check O2 (MA0236), Substantially Equivalent on 2025-04-24. Applicant: Life Spark Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Life Spark Medical, LLC
- Product code
- Code CCL
- Device class
- Class 2
- Regulation
- 21 CFR 868.1720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, UT, US
Recent devices under product code CCL
view allAdverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.