PATIENT GAS SAMPLING LINE FOR OHMEDA 6000— 510(k) K910509
Substantially EquivalentIntertech Resources, Inc.
FDA 510(k) clearance K910509 for PATIENT GAS SAMPLING LINE FOR OHMEDA 6000, Substantially Equivalent on 1991-04-17. Applicant: Intertech Resources, Inc..
Clearance details
- Applicant
- Intertech Resources, Inc.
- Product code
- Code CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Myers, FL, US
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.