FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTSCREENER-PLUS2
K Number: K090579
·
Decision Jul 7, 2009
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
13
Review Days
126
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Basic Information
- Device Name
- SMARTSCREENER-PLUS2
- K Number
- K090579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intelligent Hearing Systems
- Date Received
- March 3, 2009
- Decision Date
- July 7, 2009
- 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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Other Clearances by Intelligent Hearing Systems
| K Number | Device Name | ||
|---|---|---|---|
| K163326 | SmartEP | Sep 29, 2017 | Substantially Equivalent |
| K073384 | SMART COUPLER, MODEL M015401 | Feb 28, 2008 | Substantially Equivalent |
| K070608 | SMARTEP, MODEL M010000 | Jul 18, 2007 | Substantially Equivalent |
| 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 |
| K925648 | SMART-SCREENER (AUDITORY) | May 11, 1993 | Substantially Equivalent |