FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSHEV MODEL 2000
K Number: K874193
·
Decision Mar 21, 1988
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
5
Review Days
159
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Basic Information
- Device Name
- MICROSHEV MODEL 2000
- K Number
- K874193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Shev , Ltd.
- Date Received
- October 14, 1987
- Decision Date
- March 21, 1988
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 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 |
| K900378 | EMG OPTION FOR MICROSHEV 4000 | Apr 10, 1990 | Substantially Equivalent |
| K894608 | MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM | Dec 29, 1989 | Substantially Equivalent |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | Oct 30, 1979 | Substantially Equivalent |