FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K Number: K031713
·
Decision Aug 12, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
- K Number
- K031713
- 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
- Viasys Healthcare, Inc.
- Date Received
- June 2, 2003
- Decision Date
- August 12, 2003
- 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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