PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST— 510(k) K082237

Substantially Equivalent

Mallinckrodt Developpement France

FDA 510(k) clearance K082237 for PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST, Substantially Equivalent on 2008-10-09. Applicant: Mallinckrodt Developpement France.

Clearance details

Applicant: Mallinckrodt Developpement France
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2008-08-07
Decision date: 2008-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Boulder, CO, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.