BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE— 510(k) K931487

Substantially Equivalent

Bird Life Design

FDA 510(k) clearance K931487 for BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE, Substantially Equivalent on 1993-12-16. Applicant: Bird Life Design.

Clearance details

Applicant
Bird Life Design
Product code
Code CAI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carrollton, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAI

product code CAI
Malfunction
869
Other
1
Total
870

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.