Cleared Traditional

COLIBRI

K940041 · Icor AB · Anesthesiology
Jul 1994
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K940041 is an FDA 510(k) clearance for the COLIBRI, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on July 27, 1994, 204 days after receiving the submission on January 4, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K940041 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1994
Decision Date July 27, 1994
Days to Decision 204 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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