Revitalair 430F— 510(k) K171899

Substantially Equivalent

Oxavita Srl

FDA 510(k) clearance K171899 for Revitalair 430F, Substantially Equivalent on 2019-11-22. Applicant: Oxavita Srl.

Clearance details

Applicant: Oxavita Srl
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2017-06-26
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buenos Aires, AR

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.