FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
FibriCheck
K Number: K232804
·
Decision Jun 7, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
12
Applicant Total
2
Review Days
269
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Basic Information
- Device Name
- FibriCheck
- K Number
- K232804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2785
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qompium NV
- Date Received
- September 12, 2023
- Decision Date
- June 7, 2024
- Product Code
- QME
- 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 |
|---|---|---|---|
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | FDA class 2 | Cardiovascular |
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Other Clearances by Qompium NV
| K Number | Device Name | ||
|---|---|---|---|
| K173872 | FibriCheck | Sep 28, 2018 | Substantially Equivalent |