Cadwell Laboratories, Inc.
Kennewick, WA, US
Cadwell Laboratories, Inc. appears in FDA device records in Kennewick, WA. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 46
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 46 510(k) clearances for Cadwell Laboratories, Inc. between 1979 and 2007. The busiest year on record is 1994, with 15. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 4 |
| 1983 | 3 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 15 |
| 1995 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 2004 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061706 | CADWELL EASYNET OXIMETER MODULE | DQA | Substantially Equivalent | |
| K061705 | CADWELL EASYNET NASAL PRESSURE MODULE | MNR | Substantially Equivalent | |
| K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR | GWF | Substantially Equivalent | |
| K040986 | CADWELL LIMB MOVEMENT MODULE | LEL | Substantially Equivalent | |
| K040932 | EASYNET BODY POSITION MODULE | LEL | Substantially Equivalent | |
| K971214 | KILOWIN | GWE | Substantially Equivalent | |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | GWF | Substantially Equivalent | |
| K962457 | TWO-CHANNEL PREAMPLIFIER | GWF | Substantially Equivalent | |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | GWF | Substantially Equivalent | |
| K946094 | CADWELL EASY AMBULATORY EEG | GWQ | Substantially Equivalent | |
| K933808 | EEG CUP ELECTRODE | GXY | Substantially Equivalent | |
| K933796 | EEG NEEDLE ELECTRODE | GXZ | Substantially Equivalent | |
| K933805 | RING ELECTRODE | GXY | Substantially Equivalent | |
| K933801 | ELECTRODE, CUTANEOUS | GXY | Substantially Equivalent | |
| K933802 | CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | |
| K933807 | GROUND PLATE ELECTRODE | GXY | Substantially Equivalent | |
| K933803 | DISPOSABLE TAB ELECTRODE | GXY | Substantially Equivalent | |
| K933799 | TEN-20 CONDUCTIVE PASTE GEL | GYB | Substantially Equivalent | |
| K933797 | OMNI PREP GEL | GYB | Substantially Equivalent | |
| K933806 | MONOPOLAR EMG NEEDLE ELECTRODE | GXZ | Substantially Equivalent | |
| K933798 | NU-PREP GEL | GXB | Substantially Equivalent | |
| K933795 | CONCENTRIC EMG NEEDLE ELECTRODE | GXZ | Substantially Equivalent | |
| K933793 | GROUND/REFERENCE NEEDLE ELECTRODE | GXZ | Substantially Equivalent | |
| K933804 | LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL | GYB | Substantially Equivalent | |
| K932407 | CADWELL EASY WRITER AND EASY READER | GWQ | Substantially Equivalent | |
| K931428 | CADWELL 6200 A | GWF | Substantially Equivalent | |
| K924723 | CADWELL SIERRA | GWF | Substantially Equivalent | |
| K905059 | HIGH SPEED MAGNETIC STIMULATOR | GWF | Substantially Equivalent | |
| K895081 | PROMONTORY STIMULATING ELECTRODE | GXY | Substantially Equivalent | |
| K894276 | CADWELL FREEDOM EEG DEVICE | GWQ | Substantially Equivalent | |
| K880088 | CADWELL EXCEL | GWF | Substantially Equivalent | |
| K872183 | AMBULATORY EEG PLAYBACK | GWQ | Substantially Equivalent | |
| K863175 | EES 10 ELECTRODELESS ELECTRICAL STIMULATOR | GWF | Substantially Equivalent | |
| K860801 | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) | GWE | Substantially Equivalent | |
| K862363 | INSERT EARPHONES | GWJ | Substantially Equivalent | |
| K862361 | 40-HZ AUDITORY EVOKED RESPONSE TEST | GWJ | Substantially Equivalent | |
| K844707 | QUANTUM 84 | GWF | Substantially Equivalent | |
| K831231 | LED GOGGLES | HLX | Substantially Equivalent | |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | HLX | Substantially Equivalent | |
| K830771 | CADWELL 8400 | GWF | Substantially Equivalent | |
| K822214 | CADWELL 7400 | GWF | Substantially Equivalent | |
| K820254 | GOLD FOIL ERG ELECTRODES | HLZ | Substantially Equivalent | |
| K820031 | CADWELL 5200 | JXE | Substantially Equivalent | |
| K820040 | SC-IT IMPEDANCE TESTER | GYA | Substantially Equivalent | |
| K800648 | CADWELL 7200 | IKN | Substantially Equivalent | |
| K791235 | CADWELL 7000 ELECTROMYOGRAPH MACHINE | IKN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JXEDevice, Nerve Conduction Velocity Measurement
- LELDevice, Sleep Assessment
- HLZElectrode, Corneal
- GXYElectrode, Cutaneous
- GXZElectrode, Needle
- IKNElectromyograph, Diagnostic
- GXBEsthesiometer
- GWQFull-Montage Standard Electroencephalograph
- GYBMedia, Electroconductive
- DQAOximeter
- HLXPhotostimulator, Ac-Powered
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GWEStimulator, Photic, Evoked Response
- GYATester, Electrode/Lead, Electroencephalograph
- MNRVentilatory Effort Recorder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
