K933762

Substantially Equivalent

STB YANKAUER SUCKER/NOZZLE

Applicant
Save-T-Breath Distributors C.C.
Product code
JOL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South Africa, ZA
Download summary PDF View on FDA.gov ↗

Adverse events under product code JOL

product code JOL
Death
7
Injury
177
Malfunction
1,306
Other
1
Total
1,491

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.