FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KardiaMobile, KardiaStation
K Number: K191406
·
Decision Jan 24, 2020
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
19
Review Days
241
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Basic Information
- Device Name
- KardiaMobile, KardiaStation
- K Number
- K191406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AliveCor, Inc.
- Date Received
- May 28, 2019
- Decision Date
- January 24, 2020
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by AliveCor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252589 | Corvair Monza | Jan 9, 2026 | Substantially Equivalent |
| K231010 | Corvair | Jun 7, 2024 | Substantially Equivalent |
| K232035 | Impala | Jun 7, 2024 | Substantially Equivalent |
| K220350 | KardiaMobile 6L | May 25, 2022 | Substantially Equivalent |
| K212662 | AliveCor QT Service | Apr 26, 2022 | Substantially Equivalent |
| K211668 | KardiaMobile Card | Nov 30, 2021 | Substantially Equivalent |
| K210753 | KardiaMobile 6L | Jun 30, 2021 | Substantially Equivalent |
| K201985 | KardiaAI | Nov 12, 2020 | Substantially Equivalent |
| K183319 | Triangle System | May 10, 2019 | Substantially Equivalent |
| K182396 | KardiaMobile, KardiaStation | Apr 12, 2019 | Substantially Equivalent |