HyperSense
System, Nuclear Magnetic Resonance Imaging
GE MEDICAL SYSTEMS, LLC
The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Hypersense.
Pre-market Notification Details
| 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 |
Trademark Results [HyperSense]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.