FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUB DIS II DPOAE MEASUREMENT SYSTEM
K Number: K981460
·
Decision May 20, 1998
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
4
Review Days
27
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Basic Information
- Device Name
- CUB DIS II DPOAE MEASUREMENT SYSTEM
- K Number
- K981460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mimosa Acoustics, Inc.
- Date Received
- April 23, 1998
- Decision Date
- May 20, 1998
- 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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