510(k) K962961
K962961 is an FDA 510(k) premarket notification submitted by Surface Mount Technology, Inc. for the device "SUSTAINED PHONATION". The FDA issued a decision of Substantially Equivalent on September 9, 1996. The device falls under product code KTH (Device, Anti-Stammering), a Class I device regulated under 21 CFR 874.5840. Surface Mount Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1996
- Date Received
- July 30, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Stammering
- Device Class
- Class I
- Regulation Number
- 874.5840
- Review Panel
- EN
- Submission Type