510(k) K832907— INVASIVE MONITORING KITS

Substantially Equivalent

American Pharmaseal Div. Ahsc

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1983-08-29
Decision date: 1984-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.