510(k) K951596
K951596 is an FDA 510(k) premarket notification submitted by Arisil Medical for the device "EARCLEAR". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code MJV (Device, Inflation, Middle Ear), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1995
- Date Received
- April 7, 1995
- 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