HYPEROX 101— 510(k) K053498

Name: FDA 510(k) clearance K053498
Creator: U.S. Food and Drug Administration
Published: 2006-03-15

Substantially Equivalent

Wjo, Inc.

FDA 510(k) clearance K053498 for HYPEROX 101, Substantially Equivalent on 2006-03-15. Applicant: Wjo, Inc.. Device class: 2.

Clearance details

Applicant: Wjo, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2005-12-16
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bristol, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.