MONO 2 OXYGEN MONITOR— 510(k) K812587

Substantially Equivalent

Kantron Cardiovascular, Inc.

FDA 510(k) clearance K812587 for MONO 2 OXYGEN MONITOR, Substantially Equivalent on 1981-10-06. Applicant: Kantron Cardiovascular, Inc..

Clearance details

Applicant: Kantron Cardiovascular, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1981-09-11
Decision date: 1981-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.