MODEL 02 OXYGEN ANALYZER— 510(k) K971084

Substantially Equivalent

Oxigraf, Inc.

FDA 510(k) clearance K971084 for MODEL 02 OXYGEN ANALYZER, Substantially Equivalent on 1998-07-21. Applicant: Oxigraf, Inc..

Clearance details

Applicant: Oxigraf, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1997-03-25
Decision date: 1998-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.