MICROMED SPA

Address:VIA GIOTTO 2,Mogliano Veneto Treviso,IT

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Standard Polysomnograph With Electroencephalograph (OLV) (7) Full-Montage Standard Electroencephalograph (GWQ) (5) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (2) Stimulator, Electrical, Evoked Response (GWF) (2) Stimulator, Photic, Evoked Response (GWE) (2) Electrode, Cortical (GYC) (1)

Premarket Exempt

Clear

micromed - 08033928120736 Catalog Number :

Device Description : fixed and/or ambulatory long-term EEG recorder, 32 EEG channels

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

micromed - 08033928120743 Catalog Number :

Device Description : ambulatory recorder for EEG and polysomnography (16 EEG channels)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

micromed - 08033928120750 Catalog Number :

Device Description : long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

micromed - 08033928120798 Catalog Number :

Device Description : ambulatory recorder for EEG and polysomnography (24 EEG channels)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Micromed - 08033928120828 Catalog Number :

Device Description : The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

micromed - 08033928120880 Catalog Number :

Device Description : software for acquisition, review, storage , process and measure of biologic sign software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : GWE, OLT, GWF, GWQ

Prescription Use : Yes

Device Count : 1

Micromed - 08033928120897 Catalog Number :

Device Description : long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

Micromed - 08033928120903 Catalog Number :

Device Description : long-term EEG fixed and/or ambulatory acquisition/recording device (32 EEG channels)

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

micromed - 08033928120910 Catalog Number :

Device Description : The Micromed BRAIN QUICK system is an integrated acquisition system for physiolo The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) .The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals.

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : OLV, GWQ

Prescription Use : Yes

Device Count : 1

Micromed - 08033928120958 Catalog Number :

Device Class : 2

Duns Number: 856998166

Premarket Exempt : No

Product Code : GWE, OLT, GWF, GWQ

Prescription Use : Yes

Device Count : 1

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