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510(k) K230502

Ear Pressure Relief Device(Model:ER813B) by Ningbo Albert Novosino Co., Ltd. — Product Code MJV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2023
Date Received
February 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Inflation, Middle Ear
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances by Ningbo Albert Novosino Co., Ltd.

  • K173044 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff (November 20, 2017)

Other clearances for product code MJV

  • K252751 — Earflo (EF001) (February 10, 2026)
  • K203754 — Eustachi Ear Pressure Relief Device (February 19, 2021)
  • K073401 — EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (March 14, 2008)
  • K951596 — EARCLEAR (May 24, 1995)
  • K920840 — OTOVENT (October 5, 1992)