DELTA D-750 THERMAFLOW— 510(k) K790406
Substantially EquivalentDelta Medical Industries
FDA 510(k) clearance K790406 for DELTA D-750 THERMAFLOW, Substantially Equivalent on 1979-11-13. Applicant: Delta Medical Industries.
Clearance details
- Applicant
- Delta Medical Industries
- Product code
- Code DTZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
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.