510(k) K031978
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2003
- Date Received
- June 26, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Auditory Impedance
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type