FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIM-PRS
K Number: K024316
·
Decision Jan 6, 2003
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
37
Review Days
11
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Basic Information
- Device Name
- NIM-PRS
- K Number
- K024316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Xomed, Inc.
- Date Received
- December 26, 2002
- Decision Date
- January 6, 2003
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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