ReddyPort NIV Access Elbow

FDA 510(k) K171827 · Smd Manufacturing, LLC

Substantially Equivalent

510(k) numberK171827

Submission

Device name
ReddyPort NIV Access Elbow
Applicant
Smd Manufacturing, LLC
Salt Lake City, UT, US
Received
June 20, 2017
Decision date
January 19, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MNS – Ventilator, Continuous, Non-Life-Supporting
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5895
Specialty
Anesthesiology

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Questions and answers

When was ReddyPort NIV Access Elbow cleared by the FDA?

ReddyPort NIV Access Elbow (K171827) received a 510(k) decision of Substantially Equivalent on January 19, 2018, 213 days after the submission was received.

What is the product code of K171827?

The FDA product code is MNS – Ventilator, Continuous, Non-Life-Supporting, a Class II (moderate risk) device regulated under 21 CFR 868.5895.