The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Ansistim.
| Device ID | K141168 |
| 510k Number | K141168 |
| Device Name: | ANSISTIM |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | DYANSYS, INC. 300 NORTH BAYSHORE BLVD San Mateo, CA 94401 |
| Contact | Srini Nageshwar |
| Correspondent | Srini Nageshwar DYANSYS, INC. 300 NORTH BAYSHORE BLVD San Mateo, CA 94401 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-06 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANSISTIM 85961977 4795724 Live/Registered |
Dyansys, Inc. 2013-06-17 |