FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuVasive NuvaLine Mobile App
K Number: K162647
·
Decision May 1, 2017
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
31
Review Days
221
Basic Information
- Device Name
- NuVasive NuvaLine Mobile App
- K Number
- K162647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NUVASIVE, INCORPORATED
- Date Received
- September 22, 2016
- Decision Date
- May 1, 2017
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K153336 | VuePoint OCT System | Jan 7, 2016 | Substantially Equivalent |
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