DRSplus
Ophthalmoscope, Laser, Scanning
CenterVue SpA
The following data is part of a premarket notification filed by Centervue Spa with the FDA for Drsplus.
Pre-market Notification Details
| Device ID | K192113 |
| 510k Number | K192113 |
| Device Name: | DRSplus |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Contact | Roberto Gabriotti |
| Correspondent | Roberto Gabriotti CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-11-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08053677040116 | K192113 | 000 |
Trademark Results [DRSplus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DRSPLUS 79324732 not registered Live/Pending |
Icare Finland Oy 2021-08-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.