Halo AF Detection System— 510(k) K201208
Substantially EquivalentLivmor
FDA 510(k) clearance K201208 for Halo AF Detection System, Substantially Equivalent on 2020-09-23. Applicant: Livmor. Device class: 2.
Clearance details
- Applicant
- Livmor
- 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
- Irvine, CA, US
Recent devices under product code DXH
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