FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ELEKTA NEUROMAG WITH MAXWELL FILTER
K Number: K050035
·
Decision Jan 25, 2005
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
23
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- ELEKTA NEUROMAG WITH MAXWELL FILTER
- K Number
- K050035
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elekta Neuromag OY
- Date Received
- January 7, 2005
- Decision Date
- January 25, 2005
- Product Code
- OLX
- 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 |
|---|---|---|---|
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | FDA class 2 | Neurology |
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