Cleared Traditional

CO2 monitoring line with and without in-line filter

K143150 · Besmed Health Business Corp · Anesthesiology
Feb 2015
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K143150 is an FDA 510(k) clearance for the CO2 monitoring line with and without in-line filter, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Besmed Health Business Corp (New Taipei City, TW). The FDA issued a Cleared decision on February 5, 2015, 94 days after receiving the submission on November 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K143150 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2014
Decision Date February 05, 2015
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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