Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NObreath®

K-Number: K203695 · 2021-12-17

ApplicantBedfont Scientific, Ltd.
Decision Date2021-12-17
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NObreath® is a medical device manufactured by Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K203695. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NObreath®?

NObreath® is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Bedfont Scientific, Ltd.. The 510(k) number is K203695.

When was NObreath® approved by the FDA?

NObreath® received FDA 510(k) clearance on 2021-12-17, under approval number K203695.

What company makes NObreath®?

NObreath® is manufactured by Bedfont Scientific, Ltd..

What is the FDA product code for NObreath®?

The FDA product code for NObreath® is MXA.

Other Devices by Bedfont Scientific, Ltd.

K173238ToxCO K211918iCOquit® Smokerlyzer®

Related Devices (Code: MXA)

K170983NIOX VEROCircassia AB K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. K213611Fenom ProCaire Diagnostics, Inc. K233775Vivatmo proBosch Healthcare Solutions GmbH K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation K243926Vivatmo pro-SBosch Healthcare Solutions GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑