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FDA 510(k)

Ear Pressure Relief Device(Model:ER813B)

K-Number: K230502 · 2023-06-09

ApplicantNingbo Albert Novosino Co., Ltd.
Decision Date2023-06-09
Product CodeMJV
DecisionSubstantially Equivalent

Device Summary

Ear Pressure Relief Device(Model:ER813B) is a medical device manufactured by Ningbo Albert Novosino Co., Ltd.. It received FDA 510(k) clearance on 2023-06-09 under approval number K230502. The device is classified under product code MJV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ear Pressure Relief Device(Model:ER813B)?

Ear Pressure Relief Device(Model:ER813B) is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Ningbo Albert Novosino Co., Ltd.. The 510(k) number is K230502.

When was Ear Pressure Relief Device(Model:ER813B) approved by the FDA?

Ear Pressure Relief Device(Model:ER813B) received FDA 510(k) clearance on 2023-06-09, under approval number K230502.

What company makes Ear Pressure Relief Device(Model:ER813B)?

Ear Pressure Relief Device(Model:ER813B) is manufactured by Ningbo Albert Novosino Co., Ltd..

What is the FDA product code for Ear Pressure Relief Device(Model:ER813B)?

The FDA product code for Ear Pressure Relief Device(Model:ER813B) is MJV.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Ningbo Albert Novosino Co., Ltd.

K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

Related Devices (Code: MJV)

K203754Eustachi Ear Pressure Relief DeviceExercore, LLC K252751Earflo (EF001)Earflo, Inc.

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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