FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-Shield Multi-paried Subdermal Needle Electrodes
K Number: K142470
·
Decision Nov 5, 2014
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- E-Shield Multi-paried Subdermal Needle Electrodes
- K Number
- K142470
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuroinvent, Inc.
- Date Received
- September 3, 2014
- Decision Date
- November 5, 2014
- 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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Other Clearances by Neuroinvent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Jul 18, 2014 | Substantially Equivalent |