FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
encevis
K Number: K171720
·
Decision Apr 19, 2018
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
2
Review Days
311
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Basic Information
- Device Name
- encevis
- K Number
- K171720
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ait Austrian Institute of Technology GmbH
- Date Received
- June 12, 2017
- Decision Date
- April 19, 2018
- Product Code
- OMB
- 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 |
|---|---|---|---|
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Ait Austrian Institute of Technology GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240993 | encevis (2.1) | Sep 27, 2024 | Substantially Equivalent |