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FDA 510(k)

Eustachi Ear Pressure Relief Device

K-Number: K203754 · 2021-02-19

ApplicantExercore, LLC
Decision Date2021-02-19
Product CodeMJV
DecisionSubstantially Equivalent

Device Summary

Eustachi Ear Pressure Relief Device is a medical device manufactured by Exercore, LLC. It received FDA 510(k) clearance on 2021-02-19 under approval number K203754. The device is classified under product code MJV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eustachi Ear Pressure Relief Device?

Eustachi Ear Pressure Relief Device is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Exercore, LLC. The 510(k) number is K203754.

When was Eustachi Ear Pressure Relief Device approved by the FDA?

Eustachi Ear Pressure Relief Device received FDA 510(k) clearance on 2021-02-19, under approval number K203754.

What company makes Eustachi Ear Pressure Relief Device?

Eustachi Ear Pressure Relief Device is manufactured by Exercore, LLC.

What is the FDA product code for Eustachi Ear Pressure Relief Device?

The FDA product code for Eustachi Ear Pressure Relief Device 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: 40487675 Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea. Obesity pillars (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: MJV)

K230502Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd. K252751Earflo (EF001)Earflo, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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