510(k) K230502
K230502 is an FDA 510(k) premarket notification submitted by Ningbo Albert Novosino Co., Ltd. for the device "Ear Pressure Relief Device(Model:ER813B)". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code MJV (Device, Inflation, Middle Ear), a Class U device. Ningbo Albert Novosino Co., Ltd. has at least 1 other 510(k) clearance on record.
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