K862199

Substantially Equivalent

MEDTECH C.P.R. MASK

Applicant
The Medtech Group, Inc.
Product code
CAE
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South Planifield, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAE

product code CAE
Death
4
Total
4

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.