FibriCheck— 510(k) K173872
Substantially EquivalentQompium NV
FDA 510(k) clearance K173872 for FibriCheck, Substantially Equivalent on 2018-09-28. Applicant: Qompium NV. Device class: 2.
Clearance details
- Applicant
- Qompium NV
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hasselt, BE
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