FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Sim&Size
K Number: K212373
·
Decision Jan 27, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
6
Review Days
181
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Basic Information
- Device Name
- Sim&Size
- K Number
- K212373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sim&Cure
- Date Received
- July 30, 2021
- Decision Date
- January 27, 2022
- Product Code
- PZO
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | FDA class 2 | Radiology |
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