MONITOR, OXYGEN, MODEL 3000A— 510(k) K781209

Substantially Equivalent

Oxyair Engineering, Inc.

FDA 510(k) clearance K781209 for MONITOR, OXYGEN, MODEL 3000A, Substantially Equivalent on 1978-08-14. Applicant: Oxyair Engineering, Inc..

Clearance details

Applicant: Oxyair Engineering, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1978-07-14
Decision date: 1978-08-14
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.