510(k) K082634
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2009
- Date Received
- September 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Vestibular Analysis
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type