OXYGEN DELIVERY MEASURING DEVICE— 510(k) K851288

Substantially Equivalent

Bar-Dix, Inc.

FDA 510(k) clearance K851288 for OXYGEN DELIVERY MEASURING DEVICE, Substantially Equivalent on 1985-09-03. Applicant: Bar-Dix, Inc..

Clearance details

Applicant: Bar-Dix, Inc.
Product code: Code CAX
Advisory panel: Anesthesiology
Date received: 1985-04-01
Decision date: 1985-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frazee, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.