Nc-Stat
FDA 510(k) K060584 · Neurometrix, Inc.
510(k) numberK060584
Submission
- Device name
- Nc-Stat
- Applicant
- Neurometrix, Inc.
Waltham, MA, US - Received
- March 7, 2006
- Decision date
- July 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXE
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| K240189 | NM-01/CPT neurometer (NM-01/CPT)JXE · Traditional | Mde Orvosbiológiai Kutató, Fejleszto, | 03/26/2025SE |
| K190536 | Mediracer NCSJXE · Traditional | Mediracer OY | 09/25/2019SE |
| K070109 | Neurometrix AdvanceJXE · Traditional | Neurometrix, Inc. | 04/25/2008SE |
| K053058 | Xltek Neuropath, Model PK1070JXE · Traditional | Excel Tech. , Ltd. | 02/07/2006SE |
| K052904 | Virtual Medical Systems Model VT3000JXE · Traditional | Scientific Imaging, Inc. | 10/27/2005SE |
| K041320 | Modification to Nc-StatJXE · Traditional | Neurometrix, Inc. | 08/12/2004SE |
| K013459 | Modification of Nc-StatJXE · Traditional | Neurometrix, Inc. | 01/17/2002SE |
| K012069 | Modification To:Brevio Nerve Conduction Test InstrumentJXE · Special | Neurotron Medical, Inc. | 08/01/2001SE |
| K003508 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 01/17/2001SE |
| K001692 | Neuro Scan Medical Ststems, Model Medicor 8JXE · Traditional | Neurosoft, Inc. | 11/24/2000SE |
More from Neurosoft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152954 | QuellNUH · Traditional | 01/05/2016SE |
| K140586 | Ascend ElectrodeGXY · Traditional | 11/17/2014SE |
| K140333 | AscendNUH · Traditional | 07/03/2014SE |
| K130919 | SensusGZJ · Traditional | 07/02/2013SE |
| K121816 | Sensus ElectrodeGXY · Traditional | 11/26/2012SE |
| K121184 | SensusGZJ · Traditional | 08/02/2012SE |
| K091155 | AscendBXN · Traditional | 09/03/2009SE |
| K083322 | Neurometrix BioamplifierGWL · Traditional | 05/27/2009SE |
| K083818 | Universal ElectrodesGXY · Special | 01/21/2009SE |
| K081871 | Universal ElectrodesGXY · Traditional | 09/29/2008SE |
Questions and answers
When was Nc-Stat cleared by the FDA?
Nc-Stat (K060584) received a 510(k) decision of Substantially Equivalent on July 31, 2006, 146 days after the submission was received.
What is the product code of K060584?
The FDA product code is JXE – Device, Nerve Conduction Velocity Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1550.