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

Full-montage Standard Electroencephalograph (GWQ) (5) DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT (JXE) (4) Electromyograph, diagnostic (IKN) (4) Non-normalizing quantitative electroencephalograph software (OLT) (4) Stimulator, photic, evoked response (GWE) (4) Standard polysomnograph with electroencephalograph (OLV) (4) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (4) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (4) VENTILATORY EFFORT RECORDER (MNR) (3) DEVICE, SLEEP ASSESSMENT (LEL) (2) Photostimulator, ac-powered (HLX) (1) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Cascade - 00840067100417 Catalog Number :

Device Description : ES5-20 Stim Splitter

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100424 Catalog Number :

Device Description : ES5-100, Stim Splitter

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100431 Catalog Number :

Device Description : ES Detect Interface

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Easy Ambulatory - 00840067100455 Catalog Number :

Device Description : Easy Ambulatory Recorder

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

EasyNet - 00840067100462 Catalog Number :

Device Description : EasyNet Nasal Pressure

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : MNR

Prescription Use : No

Device Count : 1

EasyNet - 00840067100479 Catalog Number :

Device Description : EasyNet Movement

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : LEL, MNR

Prescription Use : No

Device Count : 1

EasyNet - 00840067100486 Catalog Number :

Device Description : EasyNet Position

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : MNR, LEL

Prescription Use : No

Device Count : 1

EasyNet - 00840067100493 Catalog Number :

Device Description : EasyNet SpO2

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

EasyNet - 00840067100509 Catalog Number :

Device Description : Multi Purpose

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Wave - 00840067100516 Catalog Number :

Device Description : Cascade VEP/LED Goggles

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : HLX

Prescription Use : No

Device Count : 1

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