EDINBURGH MASKER— 510(k) K800445
Substantially EquivalentFoundation For Fluency, Inc.
FDA 510(k) clearance K800445 for EDINBURGH MASKER, Substantially Equivalent on 1980-03-12. Applicant: Foundation For Fluency, Inc.. Device class: 1.
Clearance details
- Applicant
- Foundation For Fluency, Inc.
- Product code
- Code KTH
- Device class
- Class 1
- Regulation
- 21 CFR 874.5840
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KTH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.