FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTTROAE
K Number: K023859
·
Decision Jan 8, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
13
Review Days
49
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Basic Information
- Device Name
- SMARTTROAE
- K Number
- K023859
- 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
- Intelligent Hearing Systems
- Date Received
- November 20, 2002
- Decision Date
- January 8, 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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Other Clearances by Intelligent Hearing Systems
| K Number | Device Name | ||
|---|---|---|---|
| K163326 | SmartEP | Sep 29, 2017 | Substantially Equivalent |
| K090579 | SMARTSCREENER-PLUS2 | Jul 7, 2009 | 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 |
| K964426 | SMARTOAE | Feb 3, 1997 | Substantially Equivalent |
| K925648 | SMART-SCREENER (AUDITORY) | May 11, 1993 | Substantially Equivalent |