FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTI-AMP
K Number: K914876
·
Decision Jan 10, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
13
Review Days
73
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Basic Information
- Device Name
- OPTI-AMP
- K Number
- K914876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intelligent Hearing Systems
- Date Received
- October 29, 1991
- Decision Date
- January 10, 1992
- Product Code
- GWL
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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|---|---|---|---|
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| K063402 | WICK ELECTRODE, MODEL M019260 | Dec 11, 2006 | Substantially Equivalent |
| K061443 | SMART USBLITE, MODEL M011120 | Jun 23, 2006 | Substantially Equivalent |
| K052060 | OPTI-AMP DC-POWERED | Aug 31, 2005 | Substantially Equivalent |
| K031051 | SMARTEP-ASSR, MODEL M811007 | Feb 20, 2004 | Substantially Equivalent |
| K023859 | SMARTTROAE | Jan 8, 2003 | Substantially Equivalent |
| K964426 | SMARTOAE | Feb 3, 1997 | Substantially Equivalent |