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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Cardiology and cardiosurgery instruments
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Electrocardiographs
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General purpose electrocardiographs
General purpose electrocardiographs
Z12050301
307 devices
Devices
Electrocardiograph
Edan Instruments, Inc.
·
,
CN
Class IIa
FDA 510(k)
K170995
Active
Cleared 2 Jun 2017
FDA 510(k)
K212278
Active
Cleared 7 Apr 2022
+6
authorizations
CAM Connect 14 w/ BC
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
PageWriter TC35 Cardiograph
Philips Medizin Systeme Böblingen GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
EC Sense System
Cardiolex Medical AB
·
,
SE
Class IIa
CE/MDR
Cardiac Workstation 5000
Philips Medizin Systeme Böblingen GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
EKG Series
International Group medical technology and electronics GmbH
·
,
DE
Class IIa
CE/MDR
Electrocardiograph
Edan Instruments, Inc.
·
,
CN
Class IIa
CE/MDR
Electrocardiograph
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class IIa
CE/MDR
Multi-channel ECG
Shenzhen ECGMAC Medical Electronics Co., Ltd.
·
,
CN
Class IIa
CE/MDD
MAC 5 Lite Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
Height Adjustment Spacer
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
CardioSecur Pace
Personal MedSystems GmbH
·
,
DE
Class IIa
CE/MDR
Electrocardiograph
Edan Instruments, Inc.
·
,
CN
Class IIa
CE/MDR
CT8000i-2 SECA - CARDIOVIT AT-1 G2
Schiller AG
·
,
CH
Class IIa
CE/MDD
VitalScan ANS (HW10)
Medeia Group Ltd
·
,
BG
Class IIa
CE/MDR
Serial 8P Cross Cable
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
Recording paper
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
Digital Electrocardiograph
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
·
,
CN
Class IIa
CE/MDD
GUDID
on market
Electrocardiograph
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class IIa
CE/MDR
EC Sense
Cardiolex Medical AB
·
,
SE
Class IIa
CE/MDR
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