FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SAPPHIRE 4ME EMG/EP SYSTEM
K Number: K912775
·
Decision Nov 8, 1991
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
15
Review Days
137
Basic Information
- Device Name
- SAPPHIRE 4ME EMG/EP SYSTEM
- K Number
- K912775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDELEC INTL. CORP.
- Date Received
- June 24, 1991
- Decision Date
- November 8, 1991
- 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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