FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
K Number: K894911
·
Decision May 14, 1990
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
52
Applicant Total
12
Review Days
286
Basic Information
- Device Name
- SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
- K Number
- K894911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- DANTEC ELECTRONICS, INC.
- Date Received
- August 1, 1989
- Decision Date
- May 14, 1990
- 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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