FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AGRAM SPYRAL ELECTRODE
K Number: K934779
·
Decision Mar 14, 1995
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
52
Applicant Total
1
Review Days
524
Basic Information
- Device Name
- AGRAM SPYRAL ELECTRODE
- K Number
- K934779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1350
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AGRAM EXPORT-IMPORT CO.
- Date Received
- October 6, 1993
- Decision Date
- March 14, 1995
- 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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