Juno VPAP ST-A— 510(k) K153061

Substantially Equivalent

Resmed, Ltd.

FDA 510(k) clearance K153061 for Juno VPAP ST-A, Substantially Equivalent on 2016-04-13. Applicant: Resmed, Ltd..

Clearance details

Applicant: Resmed, Ltd.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2015-10-21
Decision date: 2016-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bella Vista, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.