ReddyPort NIV Access Elbow
K-Number: K171827 · 2018-01-19
ApplicantSmd Manufacturing, LLC
Decision Date2018-01-19
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ReddyPort NIV Access Elbow is a medical device manufactured by Smd Manufacturing, LLC. It received FDA 510(k) clearance on 2018-01-19 under approval number K171827. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ReddyPort NIV Access Elbow?
ReddyPort NIV Access Elbow is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Smd Manufacturing, LLC. The 510(k) number is K171827.
When was ReddyPort NIV Access Elbow approved by the FDA?
ReddyPort NIV Access Elbow received FDA 510(k) clearance on 2018-01-19, under approval number K171827.
What company makes ReddyPort NIV Access Elbow?
ReddyPort NIV Access Elbow is manufactured by Smd Manufacturing, LLC.
What is the FDA product code for ReddyPort NIV Access Elbow?
The FDA product code for ReddyPort NIV Access Elbow is MNS. This falls under the Neurology category.
Other Devices by Smd Manufacturing, LLC
Related Devices (Code: MNS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.