NObreath®— 510(k) K203695

Substantially Equivalent

Bedfont Scientific, Ltd.

FDA 510(k) clearance K203695 for NObreath®, Substantially Equivalent on 2021-12-17. Applicant: Bedfont Scientific, Ltd.. Device class: 2.

Clearance details

Applicant: Bedfont Scientific, Ltd.
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2020-12-18
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, Kent, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.