FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIOMETER
K Number: K790609
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
16
Review Days
12
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Basic Information
- Device Name
- AUDIOMETER
- K Number
- K790609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Grason-Stadler, Inc.
- Date Received
- March 29, 1979
- Decision Date
- April 10, 1979
- 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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|---|---|---|---|
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| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Apr 12, 2000 | Substantially Equivalent |
| K974237 | GSI 70 AUDIOPATH SCREENER | Feb 10, 1998 | Substantially Equivalent |
| K970324 | GSI SA60 DPOAE SYSTEM | Jun 6, 1997 | Substantially Equivalent |
| K953684 | GSI 61 CLINICAL AUDIOMETER | Oct 27, 1995 | Substantially Equivalent |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | Jul 6, 1995 | Substantially Equivalent |
| K902540 | GSI 17 SCREENING AUDIOMETER | Jul 13, 1990 | Substantially Equivalent |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | Jul 14, 1989 | Substantially Equivalent |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | Mar 13, 1987 | Substantially Equivalent |