FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K Number: K020910
·
Decision Jul 19, 2002
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
52
Applicant Total
6
Review Days
121
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Basic Information
- Device Name
- SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
- K Number
- K020910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Electrode Store, Inc.
- Date Received
- March 20, 2002
- Decision Date
- July 19, 2002
- 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 The Electrode Store, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | Aug 14, 2009 | Substantially Equivalent |
| K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | Aug 13, 2002 | Substantially Equivalent |
| K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | May 10, 2002 | Substantially Equivalent |
| K926094 | PROTECTRODE SYSTEM | Dec 6, 1995 | Substantially Equivalent |
| K932691 | PROTECTRODE SYSTEMS CONCENTRIC | Nov 16, 1995 | Substantially Equivalent |