Cleared Traditional

ReddyPort NIV Access Elbow

K171827 · Smd Manufacturing, LLC · Anesthesiology
Jan 2018
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K171827 is an FDA 510(k) clearance for the ReddyPort NIV Access Elbow, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Smd Manufacturing, LLC (Salt Lake City, US). The FDA issued a Cleared decision on January 19, 2018, 213 days after receiving the submission on June 20, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K171827 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2017
Decision Date January 19, 2018
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895