CORSCREEN— 510(k) K070614

Substantially Equivalent

Viasys Healthcare GmbH

FDA 510(k) clearance K070614 for CORSCREEN, Substantially Equivalent on 2007-05-04. Applicant: Viasys Healthcare GmbH.

Clearance details

Applicant: Viasys Healthcare GmbH
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2007-03-05
Decision date: 2007-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

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.