Cleared Traditional

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

K952325 · Icor AB · Anesthesiology
Jul 1995
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K952325 is an FDA 510(k) clearance for the ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR), a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on July 31, 1995, 74 days after receiving the submission on May 18, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K952325 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1995
Decision Date July 31, 1995
Days to Decision 74 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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