OXYCHECK OXYGEN MONITOR— 510(k) K951038

Substantially Equivalent

Oxycheck, Inc.

FDA 510(k) clearance K951038 for OXYCHECK OXYGEN MONITOR, Substantially Equivalent on 1996-01-11. Applicant: Oxycheck, Inc..

Clearance details

Applicant: Oxycheck, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1995-03-07
Decision date: 1996-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, 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.