Cleared Traditional

ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

K954402 · Icor AB · Anesthesiology
May 1996
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K954402 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 May 22, 1996, 245 days after receiving the submission on September 20, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K954402 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1995
Decision Date May 22, 1996
Days to Decision 245 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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