K992986

Substantially Equivalent

SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER

Applicant
Salter Labs
Product code
CAF
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Arvin, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF
Death
22
Injury
125
Malfunction
613
Other
11
Total
771

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.