FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HBIDB - HUMAN BRIAN INDEX SOFTWARE
K Number: K112077
·
Decision Mar 9, 2012
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
12
Applicant Total
4
Review Days
232
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Basic Information
- Device Name
- HBIDB - HUMAN BRIAN INDEX SOFTWARE
- K Number
- K112077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corscience GmbH & Co. KG
- Date Received
- July 21, 2011
- Decision Date
- March 9, 2012
- Product Code
- OLU
- 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 |
|---|---|---|---|
| OLU | Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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