Cleared Special

PICO SMOKERLYZER, MODEL EC-50

K000962 · Bedfont Scientific, Ltd. · Chemistry
Apr 2000
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K000962 is an FDA 510(k) clearance for the PICO SMOKERLYZER, MODEL EC-50, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Bedfont Scientific, Ltd. (Upchurch, Kent, GB). The FDA issued a Cleared decision on April 20, 2000, 27 days after receiving the submission on March 24, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K000962 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2000
Decision Date April 20, 2000
Days to Decision 27 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1430