Coala Heart Monitor— 510(k) K212163

Substantially Equivalent

Coala Life AB

FDA 510(k) clearance K212163 for Coala Heart Monitor, Substantially Equivalent on 2022-04-14. Applicant: Coala Life AB.

Clearance details

Applicant: Coala Life AB
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2021-07-12
Decision date: 2022-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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.