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, photic, evoked response (GWE) (9) DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT (JXE) (9) Electromyograph, diagnostic (IKN) (9) Full-montage Standard Electroencephalograph (GWQ) (9) Non-normalizing quantitative electroencephalograph software (OLT) (9) STIMULATOR, AUDITORY, EVOKED RESPONSE (GWJ) (9) STIMULATOR, ELECTRICAL, EVOKED RESPONSE (GWF) (9) Standard polysomnograph with electroencephalograph (OLV) (9) CABLE, ELECTRODE (IKD) (1) STIMULATOR, MECHANICAL, EVOKED RESPONSE (GZP) (1)

Premarket Exempt

No Yes

Clear

Sierra Summit/Ascent - 00840067100110 Catalog Number :

Device Description : Summit Tendon Hammer

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Summit/Ascent - 00840067100127 Catalog Number :

Device Description : HDA280 Sennheiser Headphone

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Ascent - 00840067100134 Catalog Number :

Device Description : Sierra Ascent Base

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Sierra Ascent - 00840067100141 Catalog Number :

Device Description : Sierra Ascent 2 Ch. Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cadwell Patented Multi-Stage Clip - 00840067100158 Catalog Number :

Device Class :

Duns Number: 098554157

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Cascade Pro - 00840067100165 Catalog Number :

Device Description : Cascade Pro Base

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100172 Catalog Number :

Device Description : ES-IX Stimulator

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade Pro - 00840067100189 Catalog Number :

Device Description : Cascade Pro 16Ch Amplifier

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100196 Catalog Number :

Device Description : Cascade TCS-1000

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Cascade - 00840067100202 Catalog Number :

Device Description : Cascade TCS-4

Device Class : 2

Duns Number: 098554157

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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