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510(k) K203754

Device
Eustachi Ear Pressure Relief Device
Applicant
Exercore, LLC
510(k) number
K203754
Product code
MJV  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-19
Date received
2020-12-23
Regulation
510(k) Premarket Notification
Classification name
Device, Inflation, Middle Ear
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ear Nose & Throat
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kevin Connelly
Address
8170 Old Carriage Ct. N, Suite 200 Shakopee MN US 55379 55379

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MJV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252751Earflo (EF001)Earflo, Inc.2026-02-10
K230502Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd.2023-06-09
K073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000Micromedics, Inc.2008-03-14
K951596EARCLEARArisil Medical1995-05-24
K920840OTOVENTAbigo Medical AB1992-10-05

Legacy Summary#

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FDA Review#

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