510(k) K832352— 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE

Substantially Equivalent

Parke-Davis Co.

Clearance details

Applicant: Parke-Davis Co.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1983-07-15
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.