Mediracer NCS
FDA 510(k) K190536 · Mediracer OY
510(k) numberK190536
Submission
- Device name
- Mediracer NCS
- Applicant
- Mediracer OY
Oulu, FI - Received
- March 4, 2019
- Decision date
- September 25, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT)JXE · Traditional | Mde Orvosbiológiai Kutató, Fejleszto, | 03/26/2025SE |
| K070109 | Neurometrix AdvanceJXE · Traditional | Neurometrix, Inc. | 04/25/2008SE |
| K060584 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 07/31/2006SE |
| 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 |
Questions and answers
When was Mediracer NCS cleared by the FDA?
Mediracer NCS (K190536) received a 510(k) decision of Substantially Equivalent on September 25, 2019, 205 days after the submission was received.
What is the product code of K190536?
The FDA product code is JXE – Device, Nerve Conduction Velocity Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1550.