Cleared Traditional

TRACHEOSTOMY CARE KIT

K941470 · Clinical Resources, Inc. · Anesthesiology
Feb 1995
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K941470 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on February 14, 1995, 323 days after receiving the submission on March 28, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K941470 FDA.gov
FDA Decision Cleared SESK
Date Received March 28, 1994
Decision Date February 14, 1995
Days to Decision 323 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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