FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO SCAN MEDICAL SYSTEMS A4000
K Number: K001562
·
Decision Aug 16, 2000
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- NEURO SCAN MEDICAL SYSTEMS A4000
- K Number
- K001562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuro Scan Labs
- Date Received
- May 19, 2000
- Decision Date
- August 16, 2000
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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