FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FONIX, MODEL 7000
K Number: K022510
·
Decision Aug 27, 2002
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
45
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- FONIX, MODEL 7000
- K Number
- K022510
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 874.3310
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Frye Electronics, Inc.
- Date Received
- July 30, 2002
- Decision Date
- August 27, 2002
- Product Code
- ETW
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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Other Clearances by Frye Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123701 | HEARLAB ACA | Apr 5, 2013 | Substantially Equivalent |
| K093006 | FONIX ,MODEL 8000 | Dec 30, 2009 | Substantially Equivalent |
| K980377 | FONIX FP35 HEARING AID ANALYZER | Mar 18, 1998 | Substantially Equivalent |
| K935400 | FONIX 3500 HEARING AID ANALYZER | Jan 14, 1994 | Substantially Equivalent |
| K913221 | TYPE FA10 AUDIOMETER | Oct 11, 1991 | Substantially Equivalent |
| K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER | Jan 22, 1990 | Substantially Equivalent |
| K872242 | TYPE 6400 REAL EAR HEARING AID ANALYZER | Jul 10, 1987 | Substantially Equivalent |
| K861571 | TYPE 6500 HEARING AID ANALYZER | May 30, 1986 | Substantially Equivalent |
| K850918 | TYPE FP30 DIGITAL HEARING AID ANALYZER | May 29, 1985 | Substantially Equivalent |
| K833883 | DIGITAL AUDIOMETER/HEARING AID 3100 | Feb 21, 1984 | Substantially Equivalent |