510(k) K813466— 4004 CONSTANT FLOW REGULATOR

Substantially Equivalent

Safety Laboratories West

Clearance details

Applicant: Safety Laboratories West
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1981-12-11
Decision date: 1982-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.