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) (10)

Premarket Exempt

Clear

Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0m - 00817111020823 Catalog Number : S17926

Device Description : Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m - 00817111020830 Catalog Number : S29724

Device Description : Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m - 00817111020847 Catalog Number : S40712

Device Description : Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6m - 00817111020854 Catalog Number : S43359

Device Description : Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0m - 00817111020861 Catalog Number : S53107

Device Description : Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0m

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, 0.6m - 00817111020878 Catalog Number : S84996

Device Description : Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.6m

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, 2.0m - 00817111020885 Catalog Number : S33059

Device Description : Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0m - 00817111020892 Catalog Number : S73426

Device Description : Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6m - 00817111020908 Catalog Number : S39154

Device Description : Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6m - 00817111020915 Catalog Number : S55638

Device Description : Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

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