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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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Neurology and neurosurgery instruments
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Various neurology and neurosurgery instruments
/
Electroconvulsive therapy (ect) equipment
Electroconvulsive therapy (ect) equipment
Z12109002
74 devices
Devices
spECTrum EMR Software
Mecta LLC
·
,
US
Class I
CE/MDR
ECG Safety Leads (White +2 more)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
EEG/ECG Five-Lead Set
Mecta LLC
·
,
US
Class I
CE/MDR
EEG Safety Leads (Gray)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
Sigma Patient Stimulus Cable
Mecta LLC
·
,
US
Class I
CE/MDR
ECT Cotton Bite Blocks Size Large
Mecta LLC
·
,
US
Class I
FDA 510(k)
K201309
Active
Cleared 4 Jun 2021
CE/MDR
Adjustable Headband
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
spECTrum Patient Stimulus Cable (replacement)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
spECTrum EEG/ECG Five-Lead Set (replacement)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
spECTrum Dual Hand-Helds without Remote
Mecta LLC
·
,
US
Class I
CE/MDR
EEG Green Reference Lead
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
EEG Safety Leads (Brown)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
Sigma Single Hand-Held Electrode Assembly with Push Button
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
MECTA Sigma 200 J
Mecta LLC
·
,
US
Class IIb
CE/MDD
ECT Treatment Cable
Somatics, LLC
·
,
US
Class I
CE/MDR
Sigma Dual Hand-Held Electrode Assembly with Push Button
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
Two Concave Stimulus Electrodes
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
ECG Safety Leads (White +2 more)
Mecta LLC
·
,
US
Class I
CE/MDR
Remote Treatment Handle
Somatics, LLC
·
,
US
Class I
CE/MDR
spECTrum Single Hand-Held w/Remote (replacement)
SigmaStim Domestic LLC
·
,
US
Class I
CE/MDR
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