MEDICON VIPAIR HIGH SPEED SYSTEM— 510(k) K042974

Name: FDA 510(k) clearance K042974
Creator: U.S. Food and Drug Administration
Published: 2005-01-13

Substantially Equivalent

Medicon EG

FDA 510(k) clearance K042974 for MEDICON VIPAIR HIGH SPEED SYSTEM, Substantially Equivalent on 2005-01-13. Applicant: Medicon EG. Device class: 2.

Clearance details

Applicant: Medicon EG
Product code: Code HBB
Device class: Class 2
Regulation: 21 CFR 882.4370
Advisory panel: Neurology
Date received: 2004-10-28
Decision date: 2005-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.