FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
K Number: K071186
·
Decision Jul 30, 2007
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
38
Review Days
91
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Basic Information
- Device Name
- MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
- K Number
- K071186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1385
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- April 30, 2007
- Decision Date
- July 30, 2007
- Product Code
- IKT
- 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 |
|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKT), ordered by most recent decision date.
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
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