VPAP Adapt SV, VPAP Tx, S9 VPAP Tx— 510(k) K161487

Substantially Equivalent

Resmed, Ltd.

FDA 510(k) clearance K161487 for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx, Substantially Equivalent on 2016-09-09. Applicant: Resmed, Ltd..

Clearance details

Applicant: Resmed, Ltd.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2016-05-31
Decision date: 2016-09-09
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.