PB 540 VENTILATOR— 510(k) K082966
Substantially EquivalentCovidien, Formerly Nellcor Puritan Bennett, Inc.
FDA 510(k) clearance K082966 for PB 540 VENTILATOR, Substantially Equivalent on 2008-10-31. Applicant: Covidien, Formerly Nellcor Puritan Bennett, Inc..
Clearance details
- Applicant
- Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Product code
- Code CBK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boulder, CO, US
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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.