Cleared Traditional

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

K071340 · Thermofisher Scientific OY · Chemistry
Oct 2007
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K071340 is an FDA 510(k) clearance for the CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on October 5, 2007, 144 days after receiving the submission on May 14, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K071340 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2007
Decision Date October 05, 2007
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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