FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
AT235
K Number: K151616
·
Decision Jul 15, 2015
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
17
Review Days
30
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Basic Information
- Device Name
- AT235
- K Number
- K151616
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interacoustics A/S
- Date Received
- June 15, 2015
- Decision Date
- July 15, 2015
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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| K163149 | VisualEyes | Apr 26, 2017 | Substantially Equivalent |
| K162037 | Eclipse with VEMP | Mar 23, 2017 | Substantially Equivalent |
| K152112 | VisualEyes | Dec 29, 2015 | Substantially Equivalent |
| K131681 | EYESEECAM VHIT | Sep 6, 2013 | Substantially Equivalent |
| K130795 | TITAN | Jun 20, 2013 | Substantially Equivalent |