510(k) K770938
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1977
- Date Received
- May 23, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Masker, Tinnitus
- Device Class
- Class II
- Regulation Number
- 874.3400
- Review Panel
- EN
- Submission Type