FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K Number: K081841
·
Decision Jul 16, 2008
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
3
Review Days
16
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Basic Information
- Device Name
- AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
- K Number
- K081841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amplivox, Ltd.
- Date Received
- June 30, 2008
- Decision Date
- July 16, 2008
- Product Code
- ETY
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
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