The following data is part of a premarket notification filed by Biorest, Inc. with the FDA for Br-2 Biorest.
| Device ID | K873920 |
| 510k Number | K873920 |
| Device Name: | BR-2 BIOREST |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | BIOREST, INC. P.O. BOX 171226 San Antonio, TX 78217 |
| Contact | Wm. A Menz |
| Correspondent | Wm. A Menz BIOREST, INC. P.O. BOX 171226 San Antonio, TX 78217 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-25 |
| Decision Date | 1987-12-29 |