OHIO CPU-1 INTENSIVE CARE VENTILATOR— 510(k) K822888

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K822888 for OHIO CPU-1 INTENSIVE CARE VENTILATOR, Substantially Equivalent on 1982-11-16. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1982-09-28
Decision date: 1982-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.