510(k) K800445
K800445 is an FDA 510(k) premarket notification submitted by Foundation For Fluency, Inc. for the device "EDINBURGH MASKER". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code KTH (Device, Anti-Stammering), a Class I device regulated under 21 CFR 874.5840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1980
- Date Received
- February 28, 1980
- 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