BIPAP AUTOSV ADVANCED— 510(k) K090539
Substantially EquivalentRespironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearance K090539 for BIPAP AUTOSV ADVANCED, Substantially Equivalent on 2009-10-30. Applicant: Respironics Inc., Sleep & Home Respiratory Group.
Clearance details
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Product code
- Code MNS
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Adverse 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.