Cadwell 7200
FDA 510(k) K800648 · Cadwell Laboratories, Inc.
510(k) numberK800648
Submission
- Device name
- Cadwell 7200
- Applicant
- Cadwell Laboratories, Inc.
Mchenry, IL, US - Received
- March 24, 1980
- Decision date
- April 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
Other 510(k)s with product code IKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172743 | Natus VikingQuestIKN · Special | Natus Neurology Incorporated | 12/19/2017SE |
| K163150 | ViMove2IKN · Special | Dorsavi, Ltd. | 07/14/2017SE |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional | Cadwell Industries, Inc. | 03/01/2017SE |
| K142494 | ViMoveIKN · Traditional | Dorsavi, Ltd. | 05/28/2015SE |
| K131094 | VimoveIKN · Traditional | Dorsa VI Pty., Ltd. | 07/11/2014SE |
| K123902 | Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional | Oktx, LLC | 09/13/2013SE |
| K123399 | Myovision 3.0 Wirefree SystemIKN · Traditional | Precision Biometrics, Inc. | 08/01/2013SE |
| K113074 | Cmap ProIKN · Traditional | Medical Technologies, Inc. | 02/02/2012SE |
| K102610 | Focus Emg DeviceIKN · Traditional | Teleemg, LLC USA | 03/04/2011SE |
| K110048 | Cersr Electromyography SystemIKN · Special | Spinematrix, Inc. | 01/26/2011SE |
More from Spinematrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061706 | Cadwell Easynet Oximeter ModuleDQA · Traditional | 03/05/2007SE |
| K061705 | Cadwell Easynet Nasal Pressure ModuleMNR · Traditional | 11/21/2006SE |
| K042350 | TES-1 Constant Voltage Electrical StimulatorGWF · Traditional | 11/03/2004SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | 07/01/2004SE |
| K040932 | Easynet Body Position ModuleLEL · Traditional | 07/01/2004SE |
| K971214 | KilowinGWE · Traditional | 06/11/1998SE |
| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962455 | Four-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K946094 | Cadwell Easy Ambulatory EEGGWQ · Traditional | 09/12/1995SE |
Questions and answers
When was Cadwell 7200 cleared by the FDA?
Cadwell 7200 (K800648) received a 510(k) decision of Substantially Equivalent on April 21, 1980, 28 days after the submission was received.
What is the product code of K800648?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.