MESI mTABLET ECG 301-002007

GUDID 03830059851103

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.

MESI d.o.o.

Electrocardiograph, professional, multichannel
Primary Device ID03830059851103
NIH Device Record Keyfc831d7d-f045-486f-a79a-a934ea7f1e4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMESI mTABLET ECG
Version Model NumberMTABSYSECG
Catalog Number301-002007
Company DUNS500719478
Company NameMESI d.o.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103830059851103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-29
Device Publish Date2023-11-21

Devices Manufactured by MESI d.o.o.

03830059851103 - MESI mTABLET ECG2023-11-29The 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.
03830059851103 - MESI mTABLET ECG2023-11-29 The MESI mTABLET ECG is a portable 12-lead resting ECG system for screening cardiac abnormalities. The system is intended for ac
03830059851523 - MESI mTABLET TBI2022-05-03 Wireless Toe Brachial Index System
03830059850366 - MESI ABPI MD2021-07-19 The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial
03830059851141 - MESI mTABLET ABI2021-07-19 The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arteri

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