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Respitrace Corp.

United StatesFDA applicant, unverified

Devices
6

What Respitrace Corp. makes

Respitrace Corp. manufactures respiratory monitoring devices, including systems for measuring and recording breath patterns, such as the RESPICOMB (a portable respiratory monitor) and the RESPITRACE (a continuous respiratory waveform recorder). Their portfolio also includes the RESPIGRAPH (a graphical analysis tool for respiratory data) and the RESPITRACE 300SC (a handheld spirometer and respiratory monitor). These devices are designed for clinical and research use to assess breathing mechanics and lung function.

The company’s respiratory monitoring devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. Their products are intended for use in the United States, where regulatory compliance is required for medical devices. No other regulatory bodies or jurisdictions are referenced in their device listings.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue6

Newest first, rows 1-6 of 6

  • Respicomb Ref K823783

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

  • Respitrace Ref K772016

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

  • Respigraph Ref K854956

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

  • Respitrace 300SC Ref K852692

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

  • Respitrace System Ref K823782

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

  • Respitrace 300SC Ref K823780

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

Frequently asked questions

How many devices does Respitrace Corp. have in the registry?

The registry currently lists 6 devices for Respitrace Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Respitrace Corp.'s devices?

Among its 6 most recently registered devices, Respitrace Corp. has devices listed in FDA 510(k) (6 devices).

What risk classes do Respitrace Corp.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Respitrace Corp.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Respitrace Corp. in the registry?

The most recently registered devices listed for Respitrace Corp. include RESPICOMB, RESPITRACE, RESPIGRAPH and RESPITRACE 300SC.

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