CADWELL INDUSTRIES, INC.

Address:909 N Kellogg St,KENNEWICK,WA,99336,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

STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (6) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (6) Stimulator, photic, evoked response (GWE) (6) Electromyograph, diagnostic (IKN) (6) DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT (JXE) (6) Non-normalizing quantitative electroencephalograph software (OLT) (5) Full-montage Standard Electroencephalograph (GWQ) (5) Standard polysomnograph with electroencephalograph (OLV) (5) ELECTRODE, CUTANEOUS (GXY) (3) STIMULATOR, MECHANICAL, EVOKED RESPONSE (GZP) (2) CABLE, ELECTRODE (IKD) (1)

Premarket Exempt

No Yes

Clear

Cascade - 00840067100219 Catalog Number :

Device Description : Cascade ES16

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : OLT, IKN, GWJ, GWF, OLV, GWQ, GWE, JXE

Prescription Use : No

Device Count : 1

Cadwell Bar Electrode - 00840067100226 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Cadwell Ring Electrode - 00840067100233 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Cadwell Ring Electrode - 00840067100240 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Cadwell Shielded Crocodile Clip Cable - 00840067100257 Catalog Number :

Device Description : CABLE, SHIELDED WALLIG CLIP-5 PIN DIN

Device Class : 2

Duns Number: 098554157

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Sierra Summit - 00840067100264 Catalog Number :

Device Description : RING/BAR ELECTRODE SWITCH BOX

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GWE, IKN, JXE, GWJ, GZP, GWF

Prescription Use : No

Device Count : 1

Cascade Elite - 00840067100271 Catalog Number :

Device Description : Cascade Elite

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : JXE, OLV, GWJ, GWE, GWF, OLT, IKN, GWQ

Prescription Use : No

Device Count : 1

Sierra Summit - 00840067100288 Catalog Number :

Device Description : VEP Cal Sensor

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : OLV, IKN, GWQ, GWE, OLT, GWF, JXE, GWJ

Prescription Use : No

Device Count : 1

Cascade Elite - 00840067100295 Catalog Number :

Device Description : Cascade Elite Power/Com Module

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : IKN, GWQ, GWJ, JXE, GWF, OLV, OLT, GWE

Prescription Use : No

Device Count : 1

Sierra Summit - 00840067100301 Catalog Number :

Device Description : Sierra Summit Remote Input Box

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GZP, GWF, IKN, OLV, GWQ, GWJ, JXE, GWE, OLT

Prescription Use : No

Device Count : 1

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