FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYPE FA10 AUDIOMETER
K Number: K913221
·
Decision Oct 11, 1991
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
13
Review Days
84
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Basic Information
- Device Name
- TYPE FA10 AUDIOMETER
- K Number
- K913221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Frye Electronics, Inc.
- Date Received
- July 19, 1991
- Decision Date
- October 11, 1991
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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| 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 |