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Leventon, S.A.

SpainFDA applicant, unverified

Devices
5

What Leventon, S.A. makes

Leventon, S.A. manufactures respiratory therapy devices, including portable oxygen concentrators like the TRI-BALL and DOSI-FLOW (Models 20 & 30), as well as flow meters such as the DOSI-FLOW and DOSI-FUSER. Their product line also covers spirometry tools, exemplified by the SPIRO-BALL, which measures lung function.

The company’s devices are classified under FDA Class II and are listed via the 510(k) pathway in the United States. No additional regulatory registries or jurisdictions are specified for these products.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue5

Newest first, rows 1-5 of 5

  • Tri-Ball Ref K994074

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Dosi-Flow, Models 20 & 30 Ref K952810

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Spiro-Ball Ref K053149

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Dosi Flow Ref K851058

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Dosi-Fuser Ref K040752

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Leventon, S.A. have in the registry?

The registry currently lists 5 devices for Leventon, S.A.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Leventon, S.A.'s devices?

Among its 5 most recently registered devices, Leventon, S.A. has devices listed in FDA 510(k) (5 devices).

What risk classes do Leventon, S.A.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Leventon, S.A.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Leventon, S.A. in the registry?

The most recently registered devices listed for Leventon, S.A. include TRI-BALL, DOSI-FLOW, MODELS 20 & 30, SPIRO-BALL and DOSI FLOW.

Generated automatically from registry data and not verified by a human reviewer.