DeviceClearance

K093525

Substantially Equivalent

ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE

Applicant
Ventlab Corp.
Product code
CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mocksville, NC, US
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.