FDA 510(k)

NObreath®

K-Number: K203695 · 2021-12-17

Decision Date2021-12-17

Product CodeMXA

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

NObreath® is the device name listed in this FDA 510(k) record. The listed applicant is Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) 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. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K203695.

When did NObreath® receive FDA 510(k) clearance?

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

Who is the listed applicant for NObreath®?

The FDA 510(k) record lists Bedfont Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NObreath®?

The FDA product code for NObreath® is MXA.

Other records listing Bedfont Scientific, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211918iCOquit® Smokerlyzer®K173238ToxCO

Related Devices (Code: MXA)

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

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.