FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QBioScan
K Number: K150804
·
Decision Oct 19, 2015
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
25
Applicant Total
1
Review Days
207
Basic Information
- Device Name
- QBioScan
- K Number
- K150804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDEIA, INC.
- Date Received
- March 26, 2015
- Decision Date
- October 19, 2015
- Product Code
- GZO
- 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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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