PARAPAC— 510(k) K960515

Substantially Equivalent

Pneupac , Ltd.

FDA 510(k) clearance K960515 for PARAPAC, Substantially Equivalent on 1996-10-10. Applicant: Pneupac , Ltd..

Clearance details

Applicant: Pneupac , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1996-02-05
Decision date: 1996-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luton Beds Lu2 Oah, 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.