PPV VAPORIZER (MODIFICATION)— 510(k) K960944

Substantially Equivalent

Penlon , Ltd.

FDA 510(k) clearance K960944 for PPV VAPORIZER (MODIFICATION), Substantially Equivalent on 1996-04-02. Applicant: Penlon , Ltd..

Clearance details

Applicant: Penlon , Ltd.
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 1996-02-13
Decision date: 1996-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxonn, GB

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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.