KardiaMobile, KardiaStation— 510(k) K191406
Substantially EquivalentAliveCor, Inc.
FDA 510(k) clearance K191406 for KardiaMobile, KardiaStation, Substantially Equivalent on 2020-01-24. Applicant: AliveCor, Inc.. Device class: 2.
Clearance details
- Applicant
- AliveCor, Inc.
- 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
- Mountain View, CA, US
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