FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EMG OPTION FOR MICROSHEV 4000
K Number: K900378
·
Decision Apr 10, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
5
Review Days
74
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Basic Information
- Device Name
- EMG OPTION FOR MICROSHEV 4000
- K Number
- K900378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Shev , Ltd.
- Date Received
- January 26, 1990
- Decision Date
- April 10, 1990
- Product Code
- JXE
- 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 |
|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | FDA class 2 | Neurology |
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Other Clearances by Micro-Shev , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K913785 | CORONET 100 | Dec 31, 1991 | Substantially Equivalent |
| K894608 | MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM | Dec 29, 1989 | Substantially Equivalent |
| K874193 | MICROSHEV MODEL 2000 | Mar 21, 1988 | Substantially Equivalent |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | Oct 30, 1979 | Substantially Equivalent |