FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NC-STAT
K Number: K060584
·
Decision Jul 31, 2006
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
18
Review Days
146
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NC-STAT
- K Number
- K060584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurometrix, Inc.
- Date Received
- March 7, 2006
- Decision Date
- July 31, 2006
- Product Code
- JXE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXE), ordered by most recent decision date.
NM-01/CPT neurometer (NM-01/CPT)
FDA 510(k)
FDA Class 2
·Neurology
Mediracer NCS
FDA 510(k)
FDA Class 2
·Neurology
NEUROMETRIX ADVANCE
FDA 510(k)
FDA Class 2
·Neurology
XLTEK NEUROPATH, MODEL PK1070
FDA 510(k)
FDA Class 2
·Neurology
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Neurometrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210046 | Quell-FM | May 18, 2022 | Unknown |
| K152954 | Quell | Jan 5, 2016 | Substantially Equivalent |
| K140586 | ASCEND ELECTRODE | Nov 17, 2014 | Substantially Equivalent |
| K140333 | ASCEND | Jul 3, 2014 | Substantially Equivalent |
| K130919 | SENSUS | Jul 2, 2013 | Substantially Equivalent |
| K121816 | SENSUS ELECTRODE | Nov 26, 2012 | Substantially Equivalent |
| K121184 | SENSUS | Aug 2, 2012 | Substantially Equivalent |
| K091155 | ASCEND | Sep 3, 2009 | Substantially Equivalent |
| K083322 | NEUROMETRIX BIOAMPLIFIER | May 27, 2009 | Substantially Equivalent |
| K083818 | UNIVERSAL ELECTRODES | Jan 21, 2009 | Substantially Equivalent |