K842829

Substantially Equivalent

HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS

Applicant: North American Instrument Corp.
Product code: DTL
Advisory panel: Cardiovascular
Date received: 1984-07-20
Decision date: 1984-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson Falls, NY, US

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.