FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTARGETING ELECTRODE
K Number: K991522
·
Decision Aug 4, 2000
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
57
Applicant Total
12
Review Days
459
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Basic Information
- Device Name
- MICROTARGETING ELECTRODE
- K Number
- K991522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FHC, Inc.
- Date Received
- May 3, 1999
- Decision Date
- August 4, 2000
- Product Code
- GZL
- 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 |
|---|---|---|---|
| GZL | Electrode, Depth | FDA class 2 | Neurology |
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