510(k) Report

FDA applicant

Tms Telemedizinische Systeme GmbH

Chemnitz, DE2 decisions2005–20060 recalls

FDA records 2 decisions for Tms Telemedizinische Systeme GmbH (Chemnitz, DE) from 2005 to 2006: 2 510(k) clearances. All are in product code DXH (Transmitters And Receivers…). Its devices cite 5 predicates, 1 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Tms Telemedizinische Systeme GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tms Telemedizinische Systeme GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tms Telemedizinische Systeme GmbH 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050670Sensor Mobile SM 100 Vitaphone 1001R RemosTms Telemedizinische Systeme GmbH · 20052cite it
  • K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 20061cites it

What has FDA decided for it lately?

  • K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006
  • K050670Sensor Mobile SM 100 Vitaphone 1001R RemosTms Telemedizinische Systeme GmbH · 2005

All 2 as Tms Telemedizinische Systeme GmbH →