The following data is part of a premarket notification filed by Biegler Gmbh with the FDA for Stivax.
Device ID | K152571 |
510k Number | K152571 |
Device Name: | Stivax |
Classification | Stimulator, Electro-acupuncture |
Applicant | BIEGLER GMBH ALLHANGSTRASSE 18A Mauerbach, AT 3001 |
Contact | Friedrich Netauschek |
Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
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 | 2015-09-09 |
Decision Date | 2016-05-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STIVAX 79127159 4438117 Live/Registered |
Biegler GmbH 2013-02-21 |