DeviceClearance

K011536

Substantially Equivalent

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

Applicant
Oridion Medical 1987 , Ltd.
Product code
CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Jerusalem, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.