FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ImmersiveView Surgical Plan (IVSP®)
K Number: K181813
·
Decision Jun 9, 2020
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
3
Review Days
704
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Basic Information
- Device Name
- ImmersiveView Surgical Plan (IVSP®)
- K Number
- K181813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immersivetouch
- Date Received
- July 6, 2018
- Decision Date
- June 9, 2020
- Product Code
- DZJ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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