DELTA D-750 THERMAFLOW— 510(k) K790406

Substantially Equivalent

Delta 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
Download summary PDFView on FDA.gov ↗

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.