FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
K Number: K052904
·
Decision Oct 27, 2005
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
3
Review Days
13
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
- VIRTUAL MEDICAL SYSTEMS MODEL VT3000
- K Number
- K052904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scientific Imaging, Inc.
- Date Received
- October 14, 2005
- Decision Date
- October 27, 2005
- Product Code
- JXE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
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
NC-STAT
FDA 510(k)
FDA Class 2
·Neurology
XLTEK NEUROPATH, MODEL PK1070
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO NC-STAT
FDA 510(k)
FDA Class 2
·Neurology