FDA.report

EART

Primary DI
17540279105018
Brand
EART
Company
Icentia Inc.
Model
10-501
Device description
ECG Analysis and Reporting Tool.
Published
2024-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions

SubmissionSupplement
K223049000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223049000CardioSTAT® ECG Test SolutionIcentia, Inc.2023-03-22DSH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17540279105018PrimaryGS10

GMDN Terms

TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Sterilization Methods

Method

Regulatory Flags

DUNS number
241983607
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
17540279200027CardioSTAT10-0062025-12-08
27540279250029CardioSTAT10-0062024-12-18
27540279250074CardioSTAT10-0062024-12-18
27540279250142CardioSTAT10-0062024-12-18
17540279100020OFIX10-0022024-03-26
17540279200072CardioSTAT10-0062024-03-26
17540279200140CardioSTAT10-0062024-03-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
27540279250074CardioSTATIcentia Inc.DSH2024-12-18
27540279250142CardioSTATIcentia Inc.DSH2024-12-18
B146EP25R0ePatch Sensor 2.5, RebuiltBRAEMAR MANUFACTURING, LLCDSH2024-06-26
04250413405640ABPM pro basic deviceSOMNOmedics GmbHDSH2024-05-08
00815187020112Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020440Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020457Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020587Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
00815187020594Matrix WearableGLOBAL INSTRUMENTATION, LLCDSH2024-04-01
17540279200072CardioSTATIcentia Inc.DSH2024-03-26
17540279200140CardioSTATIcentia Inc.DSH2024-03-26
B322H0011LD-EKGLD TECHNOLOGY, LLCDSH2024-03-05
06944413820463Holter ECG and ABP SystemEdan Instruments, Inc.DSH2023-11-30
06944413820470Holter ECG and ABP SystemEdan Instruments, Inc.DSH2023-11-30
06944413820487Holter ECG and ABP SystemEdan Instruments, Inc.DSH2023-11-30
06944413820494Holter ECG and ABP SystemEdan Instruments, Inc.DSH2023-11-30
06944413820500Holter ECG and ABP SystemEdan Instruments, Inc.DSH2023-11-30
B146EP2520ePatch 2.5, BTIBRAEMAR MANUFACTURING, LLCDSH2023-11-22
00812324000204GEMS Win ArrhythmiaCardioComm Solutions, IncDSH2023-11-09
00812324000211GEMS Win TTMCardioComm Solutions, IncDSH2023-11-09
00812324000242GEMS Win AutoAttendantCardioComm Solutions, IncDSH2023-11-09
00812324000259GEMS Win AirCardioComm Solutions, IncDSH2023-11-09
00812324000228GEMS Win TTM & ICDCardioComm Solutions, IncDSH2023-11-08
00812324000266GEMS Win HL7CardioComm Solutions, IncDSH2023-11-08
08800159500015S-Patch ExWellysis Corp.DSH2023-11-08
B146EP2510ePatch 2.5, BTHBRAEMAR MANUFACTURING, LLCDSH2023-01-20
18800069700175AT-PatchATsens Co., Ltd.DSH2022-12-23
00850043625001Strados LabsStrados Labs, Inc.DSH2022-12-02