Identity
- Trade Name
- Kardia 12L FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders. FDA UDI
- Model / Reference
- AC-027 FDA UDI
- Description
- Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B210AC0270 FDA UDI
- 510(k) Number
- K232035 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiograph, professional, multichannel
Kardia 12L by AliveCor — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiograph, professional, multichannel.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- ers2 1CH ECG Adapter US Set 5 pcs. — ergoline GmbH · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Premier Heart MCG Model VH12 — PREMIER HEART, LLC · Class II
- ELI 380 — MORTARA INSTRUMENT, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AliveCor
Sources (1)
- FDA UDI 9b26556b-fd39-4fef-9f2f-66dd2a9160eb 36 fields · synced May 30, 2026