NEUROTHERM, INC.

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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

CABLE, ELECTRODE (IKD) (1) GENERATOR, LESION, RADIOFREQUENCY (GXD) (1) PROBE, RADIOFREQUENCY LESION (GXI) (1)

Premarket Exempt

Clear

NeuroTherm - 05415067024435 Catalog Number : RF-DGP-C

Device Description : Grounding Pad Adapter Cable

Device Class : 2

Duns Number: 124023552

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

NeuroTherm™ - 05415067026576 Catalog Number : PT-KIT-S

Device Description : PodiaTherm Disposable Kit

Device Class : 2

Duns Number: 124023552

Premarket Exempt : No

Product Code : GXI, GXD

Prescription Use : Yes

Device Count : 1

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