PICO SMOKERLYZER, MODEL EC-50— 510(k) K000962

Name: FDA 510(k) clearance K000962
Creator: U.S. Food and Drug Administration
Published: 2000-04-20

Substantially Equivalent

Bedfont Scientific, Ltd.

FDA 510(k) clearance K000962 for PICO SMOKERLYZER, MODEL EC-50, Substantially Equivalent on 2000-04-20. 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: 2000-03-24
Decision date: 2000-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Upchurch, 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.