510(k) Report

FDA applicant

Bellab

Gothenburg, SE1 decision1997–19970 recalls

FDA records 1 decision for Bellab (Gothenburg, SE) in 1997: 1 510(k) clearance. All are in product code LZI (Device, Assistive Listening). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Bellab’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bellab since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bellab by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZIDevice, Assistive Listening1decision

What has FDA decided for it lately?

  • K970340Air Conduction Assistive Listening Device.Personal AmplifierBellab · 1997

The one decision as Bellab →