iCOquit® Smokerlyzer®— 510(k) K211918

Substantially Equivalent

Bedfont Scientific, Ltd.

FDA 510(k) clearance K211918 for iCOquit® Smokerlyzer®, Substantially Equivalent on 2021-12-21. Applicant: Bedfont Scientific, Ltd.. Device class: 2.

Clearance details

Applicant: Bedfont Scientific, Ltd.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2021-06-21
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, Kent, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Bedfont Scientific, Ltd.

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