STIHLER ASTOTHERM IFT 200, IFT 220— 510(k) K882361
Substantially EquivalentStihler Electronic, C/O Worldwide Regul. Services
FDA 510(k) clearance K882361 for STIHLER ASTOTHERM IFT 200, IFT 220, Substantially Equivalent on 1988-08-25. Applicant: Stihler Electronic, C/O Worldwide Regul. Services.
Clearance details
- Applicant
- Stihler Electronic, C/O Worldwide Regul. Services
- Product code
- Code LGZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingville, NY, US
Adverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
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.