FDA 510(k)
FDA class 2
Unknown
🇧🇪 Belgium
FEops HEARTguide
K Number: DEN200030
·
Decision Sep 8, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
4
Review Days
489
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Basic Information
- Device Name
- FEops HEARTguide
- K Number
- DEN200030
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.1405
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Feops NV
- Date Received
- May 7, 2020
- Decision Date
- September 8, 2021
- 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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