FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROREADER
K Number: K950986
·
Decision Nov 9, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
1
Review Days
251
Basic Information
- Device Name
- NEUROREADER
- K Number
- K950986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1570
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ARTRONICS
- Date Received
- March 3, 1995
- Decision Date
- November 9, 1995
- Product Code
- HCS
- 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 |
|---|---|---|---|
| HCS | Device, Temperature Measurement, Direct Contact, Powered | FDA class 2 | Neurology |
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