PRIMA ANAESTHESIA MACHINE— 510(k) K061102

Substantially Equivalent

Penlon , Ltd.

FDA 510(k) clearance K061102 for PRIMA ANAESTHESIA MACHINE, Substantially Equivalent on 2006-07-28. Applicant: Penlon , Ltd..

Clearance details

Applicant: Penlon , Ltd.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2006-04-19
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Barton Lane, Abingdon, GB

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.