BIRD TBIRD LEGACY VENTILATOR— 510(k) K003770

Substantially Equivalent - Subject to Tracking Reg.

Bird Products Corp.

FDA 510(k) clearance K003770 for BIRD TBIRD LEGACY VENTILATOR, Substantially Equivalent - Subject to Tracking Reg. on 2000-12-15. Applicant: Bird Products Corp..

Clearance details

Applicant
Bird Products Corp.
Product code
Code CBK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent - Subject to Tracking Reg.
Clearance type
Special
Location
Palm Spring, CA, US
Download summary PDFView on FDA.gov ↗

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.