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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Smd Manufacturing, LLC. It received FDA 510(k) clearance on 2023-07-13 under 510(k) 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. The listed applicant is Smd Manufacturing, LLC. The 510(k) number is K231064.

When did ReddyPort Elbow receive FDA 510(k) clearance?

ReddyPort Elbow received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231064.

Who is the listed applicant for ReddyPort Elbow?

The FDA 510(k) record lists Smd Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Smd Manufacturing, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171827ReddyPort NIV Access Elbow

Related Devices (Code: MNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251889myAirResmed CorpK252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK213169BPAP SystemBMC Medical Co., Ltd.K171827ReddyPort NIV Access ElbowSmd Manufacturing, LLC

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.

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