FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
LEKSELL SURGIPLAN WITH IMAGEMERGE
K Number: K033340
·
Decision Feb 12, 2004
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
35
Review Days
118
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Basic Information
- Device Name
- LEKSELL SURGIPLAN WITH IMAGEMERGE
- K Number
- K033340
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Elekta Instrument AB
- Date Received
- October 17, 2003
- Decision Date
- February 12, 2004
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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