FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
K Number: K063338
·
Decision Jan 4, 2007
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
4
Review Days
59
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Basic Information
- Device Name
- HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER
- K Number
- K063338
- 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
- Mimosa Acoustics, Inc.
- Date Received
- November 6, 2006
- Decision Date
- January 4, 2007
- 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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