SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE— 510(k) K080439

Clearance details

Applicant

Mallinckrodt Developpement France

Product code

Code BZD

Device class

Class 2

Regulation

21 CFR 868.5905

Advisory panel

Anesthesiology

Date received

2008-02-19

Decision date

2008-05-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Boulder, CO, US

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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 →