CADWELL INDUSTRIES, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3020018	3020018	CADWELL INDUSTRIES, INC.	1	Y	2026-01-01	909 N Kellogg St KENNEWICK WA US 99336

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
39529	2052786234	K971214	KILOWIN	GWE	1998-06-11
39529	1528082797	K962458	CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER	GWF	1997-01-13
39529	1670703841	K962457	TWO-CHANNEL PREAMPLIFIER	GWF	1997-01-13
39529	1046829643	K962455	FOUR-CHANNEL PREAMPLIFIER	GWF	1997-01-13
39529	1877511697	K946094	CADWELL EASY AMBULATORY EEG	GWQ	1995-09-12
39529	2062107128	K941759	SNORING SENSOR	BZQ	1994-11-10
39529	1794238317	K933808	EEG CUP ELECTRODE	GXY	1994-12-29
39529	1090531906	K933807	GROUND PLATE ELECTRODE	GXY	1994-07-26
39529	1265503082	K933805	RING ELECTRODE	GXY	1994-12-19
39529	1893625731	K933803	DISPOSABLE TAB ELECTRODE	GXY	1994-07-08
39529	1382384378	K933802	CUTANEOUS ELECTRODE	GXY	1994-09-07
39529	2062486376	K933801	ELECTRODE, CUTANEOUS	GXY	1994-10-21
39529	2026456199	K933799	TEN-20 CONDUCTIVE PASTE GEL	GYB	1994-05-27
39529	1469921437	K933798	NU-PREP GEL	GXB	1994-04-22
39529	1169597860	K933797	OMNI PREP GEL	GYB	1994-05-17
39529	1765993258	K932407	CADWELL EASY WRITER AND EASY READER	GWQ	1994-03-22
39529	1205897482	K931428	CADWELL 6200 A	GWF	1993-06-22
39529	2058885136	K924723	CADWELL SIERRA	GWF	1993-03-23
39529	1758782570	K923033	THE TRACKER	LXJ	1993-06-01
39529	1984344814	K922112	EASYFLOW	BZQ	1992-12-07
39529	1633766214	K905059	HIGH SPEED MAGNETIC STIMULATOR	GWF	1991-09-18
39529	2049384532	K903300	RESP-EZ(TM) RESPIRATORY MONITORING BELT	BZQ	1990-12-28
39529	1551935544	K895081	PROMONTORY STIMULATING ELECTRODE	GXY	1989-11-09
39529	1182614634	K894276	CADWELL FREEDOM EEG DEVICE	GWQ	1989-09-29
39529	1315046882	K880088	CADWELL EXCEL	GWF	1988-05-04
39529	1373938420	K872183	AMBULATORY EEG PLAYBACK	GWQ	1987-07-21
39529	1017147779	K863175	EES 10 ELECTRODELESS ELECTRICAL STIMULATOR	GWF	1987-01-13
39529	1468624482	K862363	INSERT EARPHONES	GWJ	1986-09-17
39529	1945301107	K862361	40-HZ AUDITORY EVOKED RESPONSE TEST	GWJ	1986-09-17
39529	1287550453	K860801	MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)	GWE	1986-11-18
39529	1965274533	K844707	QUANTUM 84	GWF	1985-05-21
39529	1017685356	K831231	LED GOGGLES	HLX	1983-05-16
39529	1096759242	K830771	CADWELL 8400	GWF	1983-04-12
39529	1797737866	K830770	CONTRAST SENSITIVITY EQUIPMENT	HLX	1983-04-28
39529	1758594244	K822214	CADWELL 7400	GWF	1982-09-24
39529	1997397514	K820254	GOLD FOIL ERG ELECTRODES	HLZ	1982-04-09
39529	2021105924	K820040	SC-IT IMPEDANCE TESTER	GYA	1982-01-28
39529	1534730494	K820031	CADWELL 5200	JXE	1982-02-04
39529	1738596519	K800648	CADWELL 7200	IKN	1980-04-21
39529	2003069380	K791235	CADWELL 7000 ELECTROMYOGRAPH MACHINE	IKN	1979-08-16
39529	1784105759	K242424	Bluebird Single-Use Respiratory Effort Belt	MNR	2024-12-18
39529	2049056432	K230415	Cadwell Guardian	GWF	2023-08-17
39529	1504061787	K192624	ApneaTrak	OLV	2020-02-20
39529	1278590142	K181466	Cadwell Zenith System	GWQ	2018-09-01
39529	1242470326	K180269	Cadwell Apollo System	GWQ	2018-07-17
39529	1431491860	K162383	Cadwell Sierra Summit, Cadwell Sierra Ascent	IKN	2017-03-01
39529	1891935849	K162199	Cascade IOMAX Intraoperative Monitor	GWF	2017-03-02
39529	1917397074	K161027	Cadwell AmpliScan	OMA	2016-11-08
39529	1292954082	K140552	CADWELL SPIKE AND SEIZURE DETECTOR	OMB	2014-07-23
39529	1158169950	K133355	CADWELL FLEX EEG/PSG	GWQ	2014-01-29
39529	1654203653	K123589	CADWELL DISPOSABLE PROBE HANDLE	PDQ	2013-03-19
39529	1831487679	K103128	CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,	ETN	2011-02-23
39529	1054490451	K082849	SILENT SLEEP	LRK	2009-07-16
39529	1536679658	K061706	CADWELL EASYNET OXIMETER MODULE	DQA	2007-03-05
39529	1952862124	K061705	CADWELL EASYNET NASAL PRESSURE MODULE	MNR	2006-11-21
39529	1704718599	K042350	TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR	GWF	2004-11-03
39529	1833481987	K040986	CADWELL LIMB MOVEMENT MODULE	LEL	2004-07-01
39529	1344746432	K040932	EASYNET BODY POSITION MODULE	LEL	2004-07-01
39529	1384583361
39529	1659387086
39529	1888035643

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
GWF	14	2023-08-17
GWQ	7	2018-09-01
GXY	7	1994-12-29
IKN	3	2017-03-01
BZQ	3	1994-11-10
MNR	2	2024-12-18
LEL	2	2004-07-01
GWE	2	1998-06-11
GYB	2	1994-05-27
GWJ	2	1986-09-17
HLX	2	1983-05-16
OLV	1	2020-02-20
OMA	1	2016-11-08
OMB	1	2014-07-23
PDQ	1	2013-03-19
ETN	1	2011-02-23
LRK	1	2009-07-16
DQA	1	2007-03-05
GXB	1	1994-04-22
LXJ	1	1993-06-01
HLZ	1	1982-04-09
JXE	1	1982-02-04
GYA	1	1982-01-28