MELYS ATRIAL FIBRILLATION SCREENING MONITOR— 510(k) K132206
Substantially EquivalentAdvanced Fluidics, LLC
FDA 510(k) clearance K132206 for MELYS ATRIAL FIBRILLATION SCREENING MONITOR, Substantially Equivalent on 2014-03-19. Applicant: Advanced Fluidics, LLC. Device class: 2.
Clearance details
- Applicant
- Advanced Fluidics, LLC
- 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
- Crofton, MD, US
Recent devices under product code DXH
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