NEUROTRONICS, INC.

Address:13800 Tech City Circle, Suite 400,Alachua,FL,32615,US

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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

Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (9) Standard Polysomnograph With Electroencephalograph (OLV) (9) Oximeter (DQA) (8) Amplifier, Physiological Signal (GWL) (4) Ventilatory Effort Recorder (MNR) (4) Full-Montage Standard Electroencephalograph (GWQ) (2) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (2) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (1)

Premarket Exempt

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Sphinx CU710 Control Unit - 00817111020205 Catalog Number :

Device Description : The Sphinx CU710 Control Unit is part of the Sphinx PMU710 system.

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, DQA

Prescription Use : Yes

Device Count : 1

Sphinx HB710 Head Box - 00817111020335 Catalog Number :

Device Description : The Sphinx HB710 Head Box is part of the Sphinx PMU710 system.

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, DQA

Prescription Use : Yes

Device Count : 1

Polysmith Version 10.0 - 00817111020748 Catalog Number :

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : GWL, MNR, DQA, OLV, OLZ

Prescription Use : Yes

Device Count : 1

Polysmith Version 9.0 - 00817111020755 Catalog Number :

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, DQA, MNR, GWL

Prescription Use : Yes

Device Count : 1

Nomad PMU800 Portable Recorder - 00817111020762 Catalog Number : N68272

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : GWL, MNR, DQA

Prescription Use : Yes

Device Count : 1

Polysmith Version 11.0 - 00817111020779 Catalog Number :

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, DQA, MNR, GWL, MLO

Prescription Use : Yes

Device Count : 1

Live View Panel Version 1.3 - 00817111020786 Catalog Number :

Device Description : Live View Panel Version 1.3

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, OLT, GWQ

Prescription Use : Yes

Device Count : 1

USB DC Box - 00817111020793 Catalog Number :

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLZ, OLV, DQA

Prescription Use : Yes

Device Count : 1

Sphinx PMU700 Polysomnography Monitoring Unit - 00817111020809 Catalog Number :

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV, OLZ, DQA

Prescription Use : Yes

Device Count : 1

Live View Panel Version 1.4 - 00817111020816 Catalog Number :

Device Description : Live View Panel Version 1.4

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : GWQ, OLT, OLV, OLZ

Prescription Use : Yes

Device Count : 1

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