DeviceClearance

K082923

Substantially Equivalent

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C

Applicant
Life-Tech, Inc.
Product code
CAC
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Stafford, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC
Death
11
Malfunction
477
Total
488

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.