OXICHECK— 510(k) K023565

Substantially Equivalent

Caradyne, Ltd.

FDA 510(k) clearance K023565 for OXICHECK, Substantially Equivalent on 2003-03-28. Applicant: Caradyne, Ltd..

Clearance details

Applicant: Caradyne, Ltd.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2002-10-23
Decision date: 2003-03-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mccordsville, IN, US

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Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.