FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K Number: K974119
·
Decision Jan 28, 1998
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
2
Review Days
89
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Basic Information
- Device Name
- DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
- K Number
- K974119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jack'S Electrodes
- Date Received
- October 31, 1997
- Decision Date
- January 28, 1998
- 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 Jack'S Electrodes
| K Number | Device Name | ||
|---|---|---|---|
| K993878 | JE 2000 | Feb 1, 2000 | Substantially Equivalent |