Cleared Traditional

FLEX BLUE

K950318 · King Systems Corp. · Anesthesiology
Feb 1995
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K950318 is an FDA 510(k) clearance for the FLEX BLUE, a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on February 13, 1995, 18 days after receiving the submission on January 26, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number K950318 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1995
Decision Date February 13, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CBH — Device, Fixation, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5770

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