Millennia Software

FDA UDI

BRAEMAR MANUFACTURING, LLC·B146C4MA000·

Holter Software

FDA UDI

Philips Medical Systems Hsg·00884838094895·Philips Holter Software w/ Zymed Alg

HScribe

FDA UDI

MORTARA INSTRUMENT, INC.·00817655021829·Holter Analysis System

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval

FDA Class 3 ·KONING BREAST CT (MODEL CBCT1000)

Frontier X Plus

FDA registration

FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED·3 products·🇮🇳 India

Bittium Faros 360 waterproof

FDA registration

Bittium Biosignals Ltd.·3 products·🇫🇮 Finland

Frontier X Plus

FDA registration

KAYNES TECHNOLOGY INDIA LIMITED·3 products·🇮🇳 India

Faros 180 and Omega Electrodes

FDA registration

Emsere, Inc.·3 products·🇺🇸 United States

Faros 180 and Omega Electrodes

FDA registration

EMSERE BV·3 products·🇳🇱 Netherlands

Boston Scientific Cardiac Diagnostic Technologies, Inc.

FDA registration

Boston Scientific Cardiac Diagnostic Technologies, Inc.·3 products·🇺🇸 United States

H-SCRIBE

FDA 510(k)

FDA Class 2 ·Cardiovascular

2010 PLUS HOLTER FOR WINDOWS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOLTER 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

RX-1 Rhythm Express Remote Cardiac Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

FDA 510(k)

FDA Class 2 ·Cardiovascular

Frontier X Plus

FDA 510(k)

FDA Class 2 ·Cardiovascular

CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDICK MHM200 PERSONAL HEART MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410

FDA 510(k)

FDA Class 2 ·Cardiovascular