M-XX OXYGEN SENSORS— 510(k) K002384
Substantially EquivalentInternational Business Strategies
FDA 510(k) clearance K002384 for M-XX OXYGEN SENSORS, Substantially Equivalent on 2000-12-15. Applicant: International Business Strategies.
Clearance details
- Applicant
- International Business Strategies
- Product code
- Code CCL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mount Pleasant, SC, US
Adverse 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.