SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM— 510(k) K974539

Substantially Equivalent

Resmed, Ltd.

FDA 510(k) clearance K974539 for SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 1998-08-06. Applicant: Resmed, Ltd..

Clearance details

Applicant: Resmed, Ltd.
Product code: Code MNT
Advisory panel: Anesthesiology
Date received: 1997-12-03
Decision date: 1998-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code MNT

product code MNT

Death: 118
Injury: 324
Malfunction: 25,451
Other: 2
Total: 25,895

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.