FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
K Number: K001692
·
Decision Nov 24, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
4
Review Days
175
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Basic Information
- Device Name
- NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
- K Number
- K001692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurosoft, Inc.
- Date Received
- June 2, 2000
- Decision Date
- November 24, 2000
- 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 |
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Other Clearances by Neurosoft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011241 | NEUROSOFT'S SOURCE | Sep 19, 2001 | Substantially Equivalent |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Feb 5, 2001 | Substantially Equivalent |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | May 17, 2000 | Substantially Equivalent |