FDA.reportPublic FDA data

MESI mTABLET ECG Extension, BANANA AHA

Primary DI
03830059853220
Brand
MESI mTABLET ECG Extension, BANANA AHA
Company
MESI d.o.o.
Model
ECGSYSCS4 EN, BANANA AHA
Catalog number
301-000512
Device description
The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for acquiring, viewing, and storing signals from adult and pediatric patients. It is a wireless system that is comprised of the control unit (mTABLET) and diagnostic module (12-lead resting ECG) used solely in a professional clinical environment by trained healthcare personnel.
Published
2025-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223670000MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.2023-07-28DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830059853220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830059853220038300598532203830059853220

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500719478
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03830059852216MESI mTABLET SPIROMTABSYSSPIRO2026-03-24
03830059851103MESI mTABLET ECGMTABSYSECG301-0020072023-11-21
03830059851523MESI mTABLET TBIMTABSYSTBI301-0037672022-04-25
03830059850366MESI ABPI MDABPIMDD301-0000802021-07-09
03830059851141MESI mTABLET ABIMTABSYSABI301-0030152021-07-09

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