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 |