510(k) K954748
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1995
- Date Received
- October 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Assistive Listening
- Device Class
- Class II
- Regulation Number
- 874.3320
- Review Panel
- EN
- Submission Type