KOO AMERICAS VALVE PEEP, MODEL KM-809— 510(k) K050918

Substantially Equivalent

Koo Americas, Inc.

FDA 510(k) clearance K050918 for KOO AMERICAS VALVE PEEP, MODEL KM-809, Substantially Equivalent on 2005-06-06. Applicant: Koo Americas, Inc..

Clearance details

Applicant: Koo Americas, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 2005-04-12
Decision date: 2005-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYE

product code BYE

Death: 5
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.