ReddyPort Elbow
K-Number: K231064 · 2023-07-13
ApplicantSmd Manufacturing, LLC
Decision Date2023-07-13
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ReddyPort Elbow is a medical device manufactured by Smd Manufacturing, LLC. It received FDA 510(k) clearance on 2023-07-13 under approval number K231064. 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 Elbow?
ReddyPort Elbow is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Smd Manufacturing, LLC. The 510(k) number is K231064.
When was ReddyPort Elbow approved by the FDA?
ReddyPort Elbow received FDA 510(k) clearance on 2023-07-13, under approval number K231064.
What company makes ReddyPort Elbow?
ReddyPort Elbow is manufactured by Smd Manufacturing, LLC.
What is the FDA product code for ReddyPort Elbow?
The FDA product code for ReddyPort 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.