MANUJET III— 510(k) K112783

Substantially Equivalent

VBM Medizintechnik GmbH

FDA 510(k) clearance K112783 for MANUJET III, Substantially Equivalent on 2011-12-22. Applicant: VBM Medizintechnik GmbH.

Clearance details

Applicant: VBM Medizintechnik GmbH
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2011-09-26
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baden-Wurttemberg, DE

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.