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) (9) Non-normalizing quantitative electroencephalograph software (OLT) (8) Standard polysomnograph with electroencephalograph (OLV) (8) Stimulator, photic, evoked response (GWE) (8) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (7) DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT (JXE) (7) Electromyograph, diagnostic (IKN) (7) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (7) Oximeter (DQA) (1) AMPLIFIER, PHYSIOLOGICAL SIGNAL (GWL) (1) Reduced- montage standard electroencephalograph (OMC) (1)

Premarket Exempt

No Yes

Clear

Sierra Wave - 00840067100523 Catalog Number :

Device Description : Acoustic Shielded Headphones

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Wave - 00840067100530 Catalog Number :

Device Description : Light Weight Headphones

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Wave - 00840067100547 Catalog Number :

Device Description : SII Bone Vibrator

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100554 Catalog Number :

Device Description : Cascade 16Ch Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100561 Catalog Number :

Device Description : Cascade Base

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade Elite - 00840067100578 Catalog Number :

Device Description : Cascade VEP/LED Quick Connect Goggles

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Easy Ambulatory - 00840067100585 Catalog Number :

Device Description : Q-Video Mobile 2

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Easy Ambulatory - 00840067100592 Catalog Number :

Device Description : 32 Ch EEG EasyNet Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

Arc Essentia - 00840067100615 Catalog Number :

Device Description : Oximeter, USB 3012LP

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Easy III - 00840067100622 Catalog Number :

Device Description : Easy III Power Com Module

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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