PER, MODEL MEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

JAH GmbH

Importer

🇩🇪 Germany

Block, Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Block, Cutting, Ent, Non-Sterile

Jig, Piston Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Jig, Piston Cutting, Ent, Non-Sterile

Crimper, Wire, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Crimper, Wire, Ent, Non-Sterile

UniCel DxH 690T Coulter Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

UniCel DxH 800 Coulter Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

UniCel DxH 600 Coulter Cellular Analysis System

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

PACEART OPTIMA™ System

FDA UDI

MEDTRONIC, INC.·00643169345058·SW POS12D13 PACEART OPTIMA MKT GLBL

ZIO AT Patch

FDA UDI

IRHYTHM TECHNOLOGIES, INC.·00869770000210·ZIO AT ECG Monitoring Service