K982239

Substantially Equivalent

CIRCUIT GUARD

Applicant
Arc Medical, Inc.
Product code
CAH
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scottdale, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAH

product code CAH
Death
7
Total
7

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.