The following data is part of a premarket notification filed by Jordan Neuroscience, Inc. with the FDA for Brainet Kit.
| Device ID | K043009 |
| 510k Number | K043009 |
| Device Name: | BRAINET KIT |
| Classification | Electrode, Cutaneous |
| Applicant | JORDAN NEUROSCIENCE, INC. 399 E. HIGHLAND AVE., STE 316 San Bernardino, CA 92404 |
| Contact | Anne Perry |
| Correspondent | Anne Perry JORDAN NEUROSCIENCE, INC. 399 E. HIGHLAND AVE., STE 316 San Bernardino, CA 92404 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865305000199 | K043009 | 000 |