MODEL 35-B ALL LEVEL COT— 510(k) K864269

Substantially Equivalent

Ferno-Washington, Inc.

FDA 510(k) clearance K864269 for MODEL 35-B ALL LEVEL COT, Substantially Equivalent on 1986-11-13. Applicant: Ferno-Washington, Inc..

Clearance details

Applicant: Ferno-Washington, Inc.
Product code: Code FPO
Advisory panel: General Hospital
Date received: 1986-10-29
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, OH, US

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.