OHIO TEMPERATURE SIMULATOR— 510(k) K832418
Substantially EquivalentAirco/Ohio Medical Products
FDA 510(k) clearance K832418 for OHIO TEMPERATURE SIMULATOR, Substantially Equivalent on 1983-09-12. Applicant: Airco/Ohio Medical Products.
Clearance details
- Applicant
- Airco/Ohio Medical Products
- Product code
- Code FMZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
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.