FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K Number: K071185
·
Decision May 30, 2007
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
38
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
- K Number
- K071185
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- April 30, 2007
- Decision Date
- May 30, 2007
- Product Code
- GXZ
- 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 |
|---|---|---|---|
| GXZ | Electrode, Needle | FDA class 2 | Neurology |
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