510(k) K093006
K093006 is an FDA 510(k) premarket notification submitted by Frye Electronics, Inc. for the device "FONIX ,MODEL 8000". The FDA issued a decision of Substantially Equivalent on December 30, 2009. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Frye Electronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2009
- Date Received
- September 28, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Hearing Aid / Earphone And Analysis Systems
- Device Class
- Class II
- Regulation Number
- 874.3310
- Review Panel
- EN
- Submission Type