FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI-DX 7000 CPT WITH AMREX ELECTRODES
K Number: K980866
·
Decision May 20, 1998
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- MEDI-DX 7000 CPT WITH AMREX ELECTRODES
- K Number
- K980866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuro-Diagnostic Assoc.
- Date Received
- February 19, 1998
- Decision Date
- May 20, 1998
- Product Code
- GWF
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Neuro-Diagnostic Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K964622 | MEDI-DX 7000 | Dec 1, 1997 | Substantially Equivalent |