The following data is part of a premarket notification filed by Elcot, Inc. with the FDA for Mf-500, Modification.
| Device ID | K911144 |
| 510k Number | K911144 |
| Device Name: | MF-500, MODIFICATION |
| 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 | 1991-02-25 |
| Decision Date | 1991-10-18 |