VPAP ADAPT— 510(k) K051364
Substantially EquivalentResmed, Ltd.
FDA 510(k) clearance K051364 for VPAP ADAPT, Substantially Equivalent on 2005-08-16. Applicant: Resmed, Ltd.. Device class: 2.
Clearance details
- Applicant
- Resmed, Ltd.
- Product code
- Code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Recent devices under product code MNS
view allMore clearances from Resmed, Ltd.
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
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.