510(k) K022510
K022510 is an FDA 510(k) premarket notification submitted by Frye Electronics, Inc. for the device "FONIX, MODEL 7000". The FDA issued a decision of Substantially Equivalent on August 27, 2002. 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
- August 27, 2002
- Date Received
- July 30, 2002
- 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