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 |