SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM— 510(k) K974539
Substantially EquivalentResmed, Ltd.
FDA 510(k) clearance K974539 for SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 1998-08-06. Applicant: Resmed, Ltd.. Device class: 2.
Clearance details
- Applicant
- Resmed, Ltd.
- Product code
- Code MNT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MNT
view allMore clearances from Resmed, Ltd.
view allAdverse events under product code MNT
product code MNT- Death
- 118
- Injury
- 324
- Malfunction
- 25,451
- Other
- 2
- Total
- 25,895
Source: openFDA MAUDE database, through . 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.