FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BALL RECORDING ELECTRODE/STIMULATION PROBE
K Number: K030517
·
Decision Aug 1, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
3
Review Days
163
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Basic Information
- Device Name
- BALL RECORDING ELECTRODE/STIMULATION PROBE
- K Number
- K030517
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1340
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viasys Healthcare, Inc.
- Date Received
- February 19, 2003
- Decision Date
- August 1, 2003
- Product Code
- GZK
- 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 |
|---|---|---|---|
| GZK | Electrode, Nasopharyngeal | FDA class 2 | Neurology |
Similar 510(k) Clearances
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