FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GSI SA60 DPOAE SYSTEM
K Number: K970324
·
Decision Jun 6, 1997
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
45
Applicant Total
16
Review Days
130
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Basic Information
- Device Name
- GSI SA60 DPOAE SYSTEM
- K Number
- K970324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3310
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Grason-Stadler, Inc.
- Date Received
- January 27, 1997
- Decision Date
- June 6, 1997
- 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 |
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