FDA.reportPublic FDA data

Kardia 12L

Primary DI
B210AC0270
Brand
Kardia 12L
Company
Alivecor, Inc.
Model
AC-027
Device 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.
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232035000ImpalaAliveCor, Inc.2024-06-07DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B210AC0270PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure54 KiloPascal101 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(855) 338 8800clinicalsupport@alivecor.com

Regulatory Flags#

DUNS number
078523613
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+AC-0192020-05-01
B210AC0290K1000AC-0292025-03-18
B210AC0210KardiaMobile CardAC-0212022-07-13
B210AC0090Kardia MobileAC-0092016-09-24
B210AC0110KardiaBand SystemAC-0112024-03-22

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