NEUROTRONICS, INC.

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

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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) (5) Amplifier, Physiological Signal (GWL) (2) Oximeter (DQA) (2) Ventilatory Effort Recorder (MNR) (2) Automatic Event Detection Software For Polysomnograph With Electroencephalograph (OLZ) (1) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (1)

Premarket Exempt

Clear

Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.2m - 00817111021127 Catalog Number : S53955

Device Description : Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.2m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.2m - 00817111021134 Catalog Number : S41319

Device Description : Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.2m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Nomad PMU800 Portable Recorder (USB) - 00817111021141 Catalog Number : N11133

Device Description : Nomad PMU800 Portable Recorder (USB)

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : DQA, MNR, GWL

Prescription Use : Yes

Device Count : 1

Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m - 00817111021158 Catalog Number : S52897

Device Description : Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0m - 00817111021165 Catalog Number : S83111

Device Description : Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Polysmith Version 12.0 - 00817111021172 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

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