The following data is part of a premarket notification filed by Medtronic with the FDA for Vs3-ir.
| Device ID | K191851 |
| 510k Number | K191851 |
| Device Name: | VS3-IR |
| Classification | Confocal Optical Imaging |
| Applicant | Medtronic 20 Hamagshimim St Petach Tikva, Hamerkaz, IL 49348 |
| Contact | Alex Chanin |
| Correspondent | Ray Kelly Arazy Group Consultants Inc. 3422 Leonardo Ln New Smyrna Beach, FL 32168 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-10 |
| Decision Date | 2019-11-25 |
| Summary: | summary |