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Electrocardiographs - software accessories
Electrocardiographs - software accessories
Z12050382
13 devices
Devices
Withings ECG Device Display
Withings SA
·
,
FR
Class IIa
CE/MDR
ECG Interpretation Software
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIa
CE/MDR
GUDID
on market
ECG app
Apple Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
Google Irregular Rhythm Notifications
Fitbit LLC
·
,
US
Class IIa
CE/MDR
Qs-335E
Shanghai Kohden Medical Electronic Instrument Corp.
·
,
CN
Class IIa
CE/MDR
ECG app
Apple Inc.
·
,
US
Class IIa
FDA De Novo
DEN180044
Active
Cleared 11 Sep 2018
FDA 510(k)
K201525
Active
Cleared 8 Oct 2020
+2
authorizations
LP Testing Software
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIa
CE/MDR
GUDID
on market
Withings ECG App Display
Withings SA
·
,
FR
Class IIa
CE/MDR
Fitbit ECG App
Fitbit LLC
·
,
US
Class IIa
CE/MDR
CE/MDD
+1
authorizations
Qs-325E
Shanghai Kohden Medical Electronic Instrument Corp.
·
,
CN
Class IIa
CE/MDR
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