FDA 510(k)
FDA unclassified
Substantially Equivalent
🇸🇪 Sweden
QBTES
K Number: K122149
·
Decision Oct 17, 2012
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
10
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- QBTES
- K Number
- K122149
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qbtech AB
- Date Received
- July 19, 2012
- Decision Date
- October 17, 2012
- Product Code
- LQD
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LQD | Recorder, Attention Task Performance | FDA unclassified | Unknown |
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