Cleared Traditional

RTC 26-C Inline Aerosol Adapter

K162753 · Instrumentation Industries, Inc. · Anesthesiology
Feb 2017
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K162753 is an FDA 510(k) clearance for the RTC 26-C Inline Aerosol Adapter, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on February 28, 2017, 151 days after receiving the submission on September 30, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K162753 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2016
Decision Date February 28, 2017
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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