FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EEG NEEDLE ELECTRODE
K Number: K933796
·
Decision Dec 29, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
46
Review Days
512
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Basic Information
- Device Name
- EEG NEEDLE ELECTRODE
- K Number
- K933796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cadwell Laboratories, Inc.
- Date Received
- August 4, 1993
- Decision Date
- December 29, 1994
- 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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| K971214 | KILOWIN | Jun 11, 1998 | Substantially Equivalent |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962457 | TWO-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | Jan 13, 1997 | Substantially Equivalent |
| K946094 | CADWELL EASY AMBULATORY EEG | Sep 12, 1995 | Substantially Equivalent |