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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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Cardiac telemetry instruments
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Electrocardiograph telemetry system transmitters
Electrocardiograph telemetry system transmitters
Z12050803
23 devices
Devices
Neck Strap
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
ECG, Respiration and SpO2 Transmitter model LX-8300M type LX-8300M
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
GUDID
on market
SpO2 Cap (For Transmitter)
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
SpO2 Cap
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
LX-1000 Series ECG, Respiration and SpO2 Transmitter LX-1300
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
Nr-314-T
Norav Medical GmbH
·
,
DE
Class IIa
CE/MDR
Disposable Portable Case
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
Cardio'B
Shl Telemedicine International Ltd.
·
,
IL
Class IIa
CE/MDD
ECG & Respiration Transmitter model LX-8100 type LX-8100
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
GUDID
on market
Em-01
EMTEL Śliwa spółka komandytowa
·
,
PL
Class IIb
CE/MDD
Disposable Case （For LX-8100）
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
MX40 - Wlan
Philips Medical Systems
·
,
US
Class IIb
CE/MDD
GUDID
on market
VitalPatch
VitalConnect, Inc.
·
,
US
Class IIa
CE/MDD
GUDID
on market
MX40 - 2.4
Philips Medical Systems
·
,
US
Class IIb
CE/MDD
GUDID
on market
Nr-314-T
Norav Medical GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
ECG Cap
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
CardioSen'C
Shl Telemedicine International Ltd.
·
,
IL
Class IIa
FDA 510(k)
K080047
Active
Cleared 11 Jul 2008
CE/MDD
+1
authorizations
Kardi Ai
KARDI AI Technologies s.r.o.
·
,
CZ
Class IIa
CE/MDR
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