CARDIOVIT AT-102 G2— 510(k) K183425

Substantially Equivalent

Schiller AG

FDA 510(k) clearance K183425 for CARDIOVIT AT-102 G2, Substantially Equivalent on 2020-03-02. Applicant: Schiller AG.

Clearance details

Applicant: Schiller AG
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2018-12-11
Decision date: 2020-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

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.