Cleared Traditional

RESPIRONICS REUSABLE HEATED TUBING

K140424 · Respironics, Inc. · Anesthesiology
Nov 2014
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K140424 is an FDA 510(k) clearance for the RESPIRONICS REUSABLE HEATED TUBING, a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II — Special Controls, product code BZE), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on November 14, 2014, 268 days after receiving the submission on February 19, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5270.

Submission Details

510(k) Number K140424 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2014
Decision Date November 14, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5270

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