CARDI-O-LIFE MODEL 8823— 510(k) K821090

Substantially Equivalent

Amertek

FDA 510(k) clearance K821090 for CARDI-O-LIFE MODEL 8823, Substantially Equivalent on 1982-07-08. Applicant: Amertek.

Clearance details

Applicant: Amertek
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1982-04-19
Decision date: 1982-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.