KOKO FILTER II— 510(k) K934475

Substantially Equivalent

Pulmonary Data Services Inst., Inc.

FDA 510(k) clearance K934475 for KOKO FILTER II, Substantially Equivalent on 1993-10-21. Applicant: Pulmonary Data Services Inst., Inc..

Clearance details

Applicant: Pulmonary Data Services Inst., Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1993-09-14
Decision date: 1993-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.