FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
K Number: K965070
·
Decision Mar 6, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
3
Review Days
85
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Basic Information
- Device Name
- SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
- K Number
- K965070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5940
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mecta Corp.
- Date Received
- December 11, 1996
- Decision Date
- March 6, 1997
- 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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