510(k) Report

FDA applicant

Rtx Healthcare A/S

Noerresundby, DK3 decisions2004–20070 recalls

FDA records 3 decisions for Rtx Healthcare A/S (Noerresundby, DK) from 2004 to 2007: 3 510(k) clearances. All are in product code DRG (Transmitters And Receivers, Physiological…). Its devices cite 5 predicates, 2 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 Rtx Healthcare A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rtx Healthcare A/S 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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 20045cite it
  • K062304DLM112 Daylink MonitorRtx Healthcare A/S · 20062cite it
  • K071953RTX3370Rtx Healthcare A/S · 20071cites it

What has FDA decided for it lately?

  • K071953RTX3370Rtx Healthcare A/S · 2007
  • K062304DLM112 Daylink MonitorRtx Healthcare A/S · 2006
  • K041816RTX3320PSTN Wireless Telehealth GatewayRtx Healthcare A/S · 2004

All 3 as Rtx Healthcare A/S →