OXIMETRIX ACCU SAT CPB— 510(k) K811391

Name: FDA 510(k) clearance K811391
Creator: U.S. Food and Drug Administration
Published: 1981-07-20

Substantially Equivalent

Oximetrix, Inc.

FDA 510(k) clearance K811391 for OXIMETRIX ACCU SAT CPB, Substantially Equivalent on 1981-07-20. Applicant: Oximetrix, Inc.. Device class: 2.

Clearance details

Applicant: Oximetrix, Inc.
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 1981-05-18
Decision date: 1981-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
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.