OXYGEN REGULATOR/FLOWMETER— 510(k) K780359

Substantially Equivalent

Erie Mfg., Co.

FDA 510(k) clearance K780359 for OXYGEN REGULATOR/FLOWMETER, Substantially Equivalent on 1978-04-04. Applicant: Erie Mfg., Co..

Clearance details

Applicant: Erie Mfg., Co.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1978-03-06
Decision date: 1978-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.