Cleared Traditional

PEDI CO2 EASY

K072220 · Westmed, Inc. · Anesthesiology
Aug 2007
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K072220 is an FDA 510(k) clearance for the PEDI CO2 EASY, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on August 23, 2007, 13 days after receiving the submission on August 10, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K072220 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2007
Decision Date August 23, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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