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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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Polysomnography instruments
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Polysomnography instruments - medical device software
Polysomnography instruments - medical device software
Z12100592
11 devices
Devices
Profusion PSG
Compumedics Limited
·
,
AU
Class IIa
CE/MDR
CE/MDD
Sleep Profiler
Advanced Brain Monitoring, Inc.
·
,
US
Class IIa
FDA 510(k)
K130007
Active
Cleared 17 Apr 2013
FDA 510(k)
K120450
Active
Cleared 19 Sep 2012
+3
authorizations
NeuroSpeed-PSG
Compumedics - alpha trace GmbH
·
,
AT
Class IIa
CE/MDD
Polysmith 12.0
Neurotronics, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
PoSAS
Advanced Brain Monitoring, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
Stowood Visi-Download
Stowood Scientific Instruments Ltd.
·
,
GB
Class IIa
CE/MDD
PC Direct Software
Respironics, Inc.
·
,
US
Class IIb
CE/MDD
Polysmith 12.2
Neurotronics, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
Sleep Profiler
Advanced Brain Monitoring, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
Sleep Profiler
Advanced Brain Monitoring, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
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