The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Hypersense.
Device ID | K162722 |
510k Number | K162722 |
Device Name: | HyperSense |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GE MEDICAL SYSTEMS, LLC 3200 GRANDVIEW BLVD Waukesha, WI 53188 |
Contact | Glen Sabin |
Correspondent | Glen Sabin GE MEDICAL SYSTEMS, LLC 3200 GRANDVIEW BLVD Waukesha, WI 53188 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-29 |
Decision Date | 2017-04-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HYPERSENSE 97739767 not registered Live/Pending |
Applied Materials, Inc. 2023-01-03 |
![]() HYPERSENSE 90733178 not registered Live/Pending |
Hyper Ice, Inc. 2021-05-25 |
![]() HYPERSENSE 86382207 4847354 Live/Registered |
Chou, Belle L 2014-09-01 |
![]() HYPERSENSE 78673582 3249011 Dead/Cancelled |
OXFORD INSTRUMENTS INDUSTRIAL PRODUCTS LIMITED 2005-07-19 |
![]() HYPERSENSE 74335862 1789215 Dead/Cancelled |
Simons, Douglas P. 1992-12-01 |