Documento fuente o registro público

FDA 510(k) K203695 — NObreath®

FDA 510(k) index record K203695. Device: NObreath®. Applicant as listed: Bedfont Scientific, Ltd.. Decision date: 2021-12-17.

OtherU.S. Food and Drug Administration (FDA)2021-12-17

Fuente

"device_name": "NObreath®"
api.fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

References

FDA 510(k) public index record K203695.

Device name: NObreath®. Applicant as listed: Bedfont Scientific, Ltd..

Decision date: 2021-12-17. Decision wording: Substantially Equivalent.

Product code: MXA. Regulation: 21 CFR 862.3080. Medical specialty: Clinical Toxicology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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FDA 510(k) K203695 — NObreath®

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