510(k) K982441
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1998
- Date Received
- July 14, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type