IFUSION
Camera, Ophthalmic, Ac-powered
OPTOVUE, INC.
The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Ifusion.
Pre-market Notification Details
| Device ID | K130656 |
| 510k Number | K130656 |
| Device Name: | IFUSION |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPTOVUE, INC. 2800 Bayview Dr Fremont, CA 94538 |
| Contact | William "bill" Jackson |
| Correspondent | William "bill" Jackson OPTOVUE, INC. 2800 Bayview Dr Fremont, CA 94538 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858848006650 | K130656 | 000 |
| 00858848006179 | K130656 | 000 |
| 00858848006186 | K130656 | 000 |
| 00858848006193 | K130656 | 000 |
| 00858848006209 | K130656 | 000 |
| 00858848006230 | K130656 | 000 |
| 00858848006247 | K130656 | 000 |
| 00858848006292 | K130656 | 000 |
| 00858848006308 | K130656 | 000 |
| 00858848006629 | K130656 | 000 |
| 00858848006636 | K130656 | 000 |
| 00858848006643 | K130656 | 000 |
| 00858848006766 | K130656 | 000 |
Trademark Results [IFUSION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IFUSION 86007047 4625856 Live/Registered |
Optovue, Inc. 2013-07-10 |
 IFUSION 85246152 4028473 Dead/Cancelled |
Altigen Communications, Inc. 2011-02-18 |
 IFUSION 78857084 not registered Dead/Abandoned |
GENTEC 2006-04-07 |
 IFUSION 76074827 not registered Dead/Abandoned |
Waller, Stephen Mark 2000-06-20 |
 IFUSION 75934604 2700808 Dead/Cancelled |
iFusion, LLC 2000-03-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.