FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K Number: K051384
·
Decision Jul 11, 2005
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
91
Review Days
45
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Basic Information
- Device Name
- MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
- K Number
- K051384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nuvasive, Inc.
- Date Received
- May 27, 2005
- Decision Date
- July 11, 2005
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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