Cleared Traditional

BRONCHOSCOPY ELBOW

K132168 · Respironics, Inc. · Anesthesiology
Nov 2013
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K132168 is an FDA 510(k) clearance for the BRONCHOSCOPY ELBOW, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 20, 2013, 131 days after receiving the submission on July 12, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K132168 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2013
Decision Date November 20, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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