CARD GUARD, MODEL CG-6550

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEMORYTRACE ATM MODEL 4222

FDA 510(k)

FDA Class 2 ·Cardiovascular

TM2000 EASYTRACE PLUS RECEIVING CENTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOOP RECORDER VITAPHONE, 3100 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATIENT ALERT MODEL 555

FDA 510(k)

FDA Class 2 ·Cardiovascular

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

FDA 510(k)

FDA Class 2 ·Cardiovascular

PER, MODEL MEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

M.I.Tech Co., Ltd

Manufacturer

🇰🇷 South Korea·809 Basic UDI-DIs·809 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

M&S Technologies ACUITYex

FDA UDI

The Hilsinger Company Parent LLC·00850040295238·M&S Technologies ACUITYex

OMRON HEALTHCARE Co., Ltd. Matsusaka Factory

FDA registration

OMRON HEALTHCARE Co., Ltd. Matsusaka Factory·4 products·🇯🇵 Japan

Zio AT device

FDA registration

iRhythm Technologies, Inc.·4 products·🇺🇸 United States

Zio AT device

FDA registration

IRHYTHM TECHNOLOGIES, INC.·4 products·🇺🇸 United States

Paceart Optima System 1.6 with Analytics

FDA registration

MEDTRONIC, INC.·4 products·🇺🇸 United States

Zio AT device

FDA registration

IRHYTHM TECHNOLOGIES, INC.·4 products·🇺🇸 United States

Zio AT device

FDA registration

iRhythm Technologies, Inc.·4 products·🇺🇸 United States

K202228

FDA registration

Omron Healthcare, Inc.·4 products·🇺🇸 United States

Paceart Optima System 1.6 with Analytics

FDA registration

Medtronic Engineering and Innovation Center (MEIC)·4 products·🇮🇳 India

OMRON HEALTHCARE CO., LTD.

FDA registration

OMRON HEALTHCARE CO., LTD.·4 products·🇯🇵 Japan