The following data is part of a premarket notification filed by Auri-stim Medical, Inc. with the FDA for Net-2000 Microcurrent Stimulator.
| Device ID | K060158 |
| 510k Number | K060158 |
| Device Name: | NET-2000 MICROCURRENT STIMULATOR |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | AURI-STIM MEDICAL, INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward AURI-STIM MEDICAL, INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-20 |
| Decision Date | 2006-10-13 |
| Summary: | summary |