FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMART USBLITE, MODEL M011120
K Number: K061443
·
Decision Jun 23, 2006
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
13
Review Days
30
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Basic Information
- Device Name
- SMART USBLITE, MODEL M011120
- K Number
- K061443
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intelligent Hearing Systems
- Date Received
- May 24, 2006
- Decision Date
- June 23, 2006
- Product Code
- GWJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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