FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
touchTymp
K Number: K162210
·
Decision Nov 16, 2016
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
2
Review Days
103
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Basic Information
- Device Name
- touchTymp
- K Number
- K162210
- 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
- Maico Diagnostics GmbH
- Date Received
- August 5, 2016
- Decision Date
- November 16, 2016
- 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
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Other Clearances by Maico Diagnostics GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K171506 | Easyscreen | Aug 29, 2017 | Substantially Equivalent |