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 the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Albert Novosino Co., Ltd.. It received FDA 510(k) clearance on 2023-06-09 under 510(k) 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. The listed applicant is Ningbo Albert Novosino Co., Ltd.. The 510(k) number is K230502.

When did Ear Pressure Relief Device(Model:ER813B) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ear Pressure Relief Device(Model:ER813B)?

The FDA 510(k) record lists Ningbo Albert Novosino Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ningbo Albert Novosino Co., Ltd. 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.

K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

Related Devices (Code: MJV)

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