SIGMA ALPHA VAPORIZER— 510(k) K060331

Name: FDA 510(k) clearance K060331
Creator: U.S. Food and Drug Administration
Published: 2006-05-10

Substantially Equivalent

Penlon Limited

FDA 510(k) clearance K060331 for SIGMA ALPHA VAPORIZER, Substantially Equivalent on 2006-05-10. Applicant: Penlon Limited. Device class: 2.

Clearance details

Applicant: Penlon Limited
Product code: Code CAD
Device class: Class 2
Regulation: 21 CFR 868.5880
Advisory panel: Anesthesiology
Date received: 2006-02-09
Decision date: 2006-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sussex, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.