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 TH01 Thermocouple Sensor, 1.5mm DIN, 2.0m - 00817111021028 Catalog Number : S28085

Device Description : Serenity TH01 Thermocouple 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 TH01 Thermocouple Sensor, 249 Keyhole, 0.6m - 00817111021035 Catalog Number : S40050

Device Description : Serenity TH01 Thermocouple Sensor, 249 Keyhole, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor, 249 Keyhole, 2.0m - 00817111021042 Catalog Number : S40661

Device Description : Serenity TH01 Thermocouple Sensor, 249 Keyhole, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 0.6m - 00817111021059 Catalog Number : S60012

Device Description : Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m - 00817111021066 Catalog Number : S53260

Device Description : Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m - 00817111021073 Catalog Number : S58317

Device Description : Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 0.6m - 00817111021080 Catalog Number : S21109

Device Description : Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 0.6m

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 2.0m - 00817111021097 Catalog Number : S47581

Device Description : Serenity TH01 Thermocouple Sensor w/ Hanger, 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, 0.2m - 00817111021103 Catalog Number : S75163

Device Description : Serenity RIP01 RIP Driver, Abdomen, 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, Abdomen, 249 Keyhole, 0.2m - 00817111021110 Catalog Number : S50986

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

Device Class : 2

Duns Number: 036405363

Premarket Exempt : No

Product Code : OLV

Prescription Use : Yes

Device Count : 1

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