PURITAN BENNETT LEGENDAIR XL2— 510(k) K070899
Substantially EquivalentNellcor Puritan Bennett
FDA 510(k) clearance K070899 for PURITAN BENNETT LEGENDAIR XL2, Substantially Equivalent on 2007-12-13. Applicant: Nellcor Puritan Bennett. Device class: 2.
Clearance details
- Applicant
- Nellcor Puritan Bennett
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code CBK
view allAdverse 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 →
Recalls naming K070899
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070899.
Data sourced from openFDA. This site is unofficial and independent of the FDA.