FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MF-500, MODIFICATION
K Number: K911144
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
2
Review Days
235
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Basic Information
- Device Name
- MF-500, MODIFICATION
- K Number
- K911144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5940
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Elcot, Inc.
- Date Received
- February 25, 1991
- Decision Date
- October 18, 1991
- Product Code
- QGH
- 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 |
|---|---|---|---|
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | FDA class 2 | Neurology |
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Other Clearances by Elcot, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863815 | ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 | Jun 2, 1987 | Substantially Equivalent |