The following data is part of a premarket notification filed by Elcot, Inc. with the FDA for Electroconvulsive Therapy Device, Model Mf-1000.
| Device ID | K863815 |
| 510k Number | K863815 |
| Device Name: | ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 |
| Classification | Device, Electroconvulsive Therapy |
| Applicant | ELCOT, INC. 14 EAST 60TH ST. New York, NY 10022 |
| Contact | Ivan G Schick |
| Correspondent | Ivan G Schick ELCOT, INC. 14 EAST 60TH ST. New York, NY 10022 |
| Product Code | GXC |
| CFR Regulation Number | 882.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1987-06-02 |