PNEUPAC PARAPAC PLUS— 510(k) K123957

Substantially Equivalent

Smiths Medical International , Ltd.

FDA 510(k) clearance K123957 for PNEUPAC PARAPAC PLUS, Substantially Equivalent on 2013-09-16. Applicant: Smiths Medical International , Ltd..

Clearance details

Applicant: Smiths Medical International , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2012-12-21
Decision date: 2013-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luton, Bedfordshire, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.