CADWELL INDUSTRIES, INC.

CADWELL INDUSTRIES, INC.

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

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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

Full-montage Standard Electroencephalograph (GWQ) (7) Non-normalizing quantitative electroencephalograph software (OLT) (7) Stimulator, photic, evoked response (GWE) (7) Standard polysomnograph with electroencephalograph (OLV) (7) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (4) Electromyograph, diagnostic (IKN) (4) DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT (JXE) (4) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (4) Reduced- montage standard electroencephalograph (OMC) (3) AMPLIFIER, PHYSIOLOGICAL SIGNAL (GWL) (3) ELECTRODE, CUTANEOUS (GXY) (2) STIMULATOR, NERVE (ETN) (1)

Premarket Exempt

No Yes

Clear

Cadwell EEG Gold Cup Electrode - 00840067100004 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Sierra Summit - 00840067100011 Catalog Number :

Device Description : Sierra Summit StimTroller Plus

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cadwell Disposable Ball-Tip Probe - 00840067100028 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

Sierra Summit - 00840067100035 Catalog Number :

Device Description : Sierra Summit Base

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cadwell Single Disc Electrode - 00840067100059 Catalog Number :

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Arc Essentia - 00840067100066 Catalog Number :

Device Description : Arc Essentia EEG Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : OLT, OMC, GWL, GWE, OLV, GWQ

Prescription Use : No

Device Count : 1

Arc - 00840067100073 Catalog Number :

Device Description : Arc Photic Stim

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GWL, GWE, OMC, OLT, GWQ, OLV

Prescription Use : No

Device Count : 1

Arc Essentia - 00840067100080 Catalog Number :

Device Description : Essentia Remote Input Box

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GWL, OLT, OMC, OLV, GWQ, GWE

Prescription Use : No

Device Count : 1

Sierra Summit - 00840067100097 Catalog Number :

Device Description : Sierra Summit 12 Ch. Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Summit - 00840067100103 Catalog Number :

Device Description : Sierra Summit 2 Ch. Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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