510(k) K863815
K863815 is an FDA 510(k) premarket notification submitted by Elcot, Inc. for the device "ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000". The FDA issued a decision of Substantially Equivalent on June 2, 1987. The device falls under product code QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder), a Class II device regulated under 21 CFR 882.5940. Elcot, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1987
- Date Received
- September 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
- Device Class
- Class II
- Regulation Number
- 882.5940
- Review Panel
- NE
- Submission Type
Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.