COR12+— 510(k) K091505

Name: FDA 510(k) clearance K091505
Creator: U.S. Food and Drug Administration
Published: 2009-06-10

Substantially Equivalent

Viasys Healthcare GmbH

FDA 510(k) clearance K091505 for COR12+, Substantially Equivalent on 2009-06-10. Applicant: Viasys Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Viasys Healthcare GmbH
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2009-05-21
Decision date: 2009-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

Download summary PDF View on FDA.gov ↗

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K243603 — AeviceMD2025-05-05

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K080510 — VIP PULMONARY FUNCTION SYSTEM2008-08-20
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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.