510(k) K871652
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1987
- Date Received
- April 28, 1987
- Clearance Type
- Traditional
- 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