The following data is part of a premarket notification filed by Seaward Group with the FDA for Unipulse.
Device ID | K182905 |
510k Number | K182905 |
Device Name: | UniPulse |
Classification | Tester, Defibrillator |
Applicant | Seaward Group 15-18 Bracken Hill Peterlee, GB Sr8 2sw |
Contact | Jim Wallace |
Correspondent | Robert Steurer Steurer Consulting Group 800 Blue Quail Rd Keller, TX 76248 |
Product Code | DRL |
CFR Regulation Number | 870.5325 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-16 |
Decision Date | 2018-12-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNIPULSE 79128870 4457131 Live/Registered |
Unipulse Corporation 2012-07-09 |
UNIPULSE 76573121 not registered Dead/Abandoned |
Unico, Inc. 2004-01-30 |
UNIPULSE 76571805 not registered Dead/Abandoned |
Unico, Inc. 2004-01-26 |
UNIPULSE 75215855 2103605 Live/Registered |
AMADA MIYACHI AMERICA, INC. 1996-12-19 |
UNIPULSE 74237586 1738001 Live/Registered |
UNIWAVE, INC. 1992-01-14 |