CERION OXY THRESHOLD ALARM— 510(k) K880448

Substantially Equivalent

Ceramatec, Inc.

FDA 510(k) clearance K880448 for CERION OXY THRESHOLD ALARM, Substantially Equivalent on 1988-03-21. Applicant: Ceramatec, Inc..

Clearance details

Applicant: Ceramatec, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1988-02-02
Decision date: 1988-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.