The following data is part of a premarket notification filed by Medical Consultants Intl. Ltd. with the FDA for Liss Cranial Stimulator Model Sbl201-m.
| Device ID | K894515 |
| 510k Number | K894515 |
| Device Name: | LISS CRANIAL STIMULATOR MODEL SBL201-M |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE Glen Rock, NJ 07452 |
| Contact | Saul Liss |
| Correspondent | Saul Liss MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE Glen Rock, NJ 07452 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1990-05-03 |