The following data is part of a premarket notification filed by Medcraft Corp. with the FDA for Electroshock Unit Neurology Model B-25.
| Device ID | K860467 |
| 510k Number | K860467 |
| Device Name: | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 |
| Classification | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder |
| Applicant | MEDCRAFT CORP. 433 BOSTON POST RD. Darien, CT 06820 |
| Contact | Chyung |
| Correspondent | Chyung MEDCRAFT CORP. 433 BOSTON POST RD. Darien, CT 06820 |
| Product Code | QGH |
| CFR Regulation Number | 882.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-06 |
| Decision Date | 1986-11-10 |