OXYCHEK OXYGEN ANALYZER— 510(k) K942593

Substantially Equivalent

Nidek Medical Products, Inc.

FDA 510(k) clearance K942593 for OXYCHEK OXYGEN ANALYZER, Substantially Equivalent on 1995-05-03. Applicant: Nidek Medical Products, Inc..

Clearance details

Applicant: Nidek Medical Products, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1994-06-01
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, 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.