510(k) K970687
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1997
- Date Received
- February 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Group And Auditory Trainer
- Device Class
- Class II
- Regulation Number
- 874.3320
- Review Panel
- EN
- Submission Type