FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
K Number: K945120
·
Decision Oct 26, 1995
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
7
Review Days
372
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Basic Information
- Device Name
- THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
- K Number
- K945120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5940
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somatics, Inc.
- Date Received
- October 19, 1994
- Decision Date
- October 26, 1995
- 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 Somatics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992269 | VENTIL-A ORAL PROTECTOR | Oct 25, 1999 | Substantially Equivalent |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Jun 2, 1989 | Substantially Equivalent |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Mar 14, 1989 | Substantially Equivalent |
| K882809 | THYMAPAD | Sep 27, 1988 | Substantially Equivalent |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Nov 3, 1986 | Substantially Equivalent |
| K843923 | THYMATRON | Dec 3, 1984 | Substantially Equivalent |