MANUJET III— 510(k) K112783

Clearance details

Applicant

VBM Medizintechnik GmbH

Product code

Code BTL

Device class

Class 2

Regulation

21 CFR 868.5925

Advisory panel

Anesthesiology

Date received

2011-09-26

Decision date

2011-12-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Baden-Wurttemberg, DE

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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 →