THE INCOURAGE SYSTEM— 510(k) K051383

Substantially Equivalent

Respiratory Technologies, Incorporated

FDA 510(k) clearance K051383 for THE INCOURAGE SYSTEM, Substantially Equivalent on 2005-06-17. Applicant: Respiratory Technologies, Incorporated.

Clearance details

Applicant: Respiratory Technologies, Incorporated
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2005-05-27
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeville, MN, US

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.