510(k) K171265
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2017
- Date Received
- May 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tympanometer
- Device Class
- Class II
- Regulation Number
- 874.1090
- Review Panel
- EN
- Submission Type