FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
FEops HEARTguide
K Number: K214066
·
Decision Feb 25, 2022
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
4
Review Days
60
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Basic Information
- Device Name
- FEops HEARTguide
- K Number
- K214066
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1405
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Feops NV
- Date Received
- December 27, 2021
- Decision Date
- February 25, 2022
- Product Code
- QQI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| QQI | Interventional Cardiovascular Implant Simulation Software Device | FDA class 2 | Cardiovascular |
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