The following data is part of a premarket notification filed by Medtronic with the FDA for Vs3-ir.
| Device ID | K183453 |
| 510k Number | K183453 |
| 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. 68 Southwood Terrace Southbury, CT 06488 |
| Product Code | OWN |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GWG |
| Subsequent Product Code | HRX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-12-13 |
| Decision Date | 2019-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813040013766 | K183453 | 000 |
| 10813040013759 | K183453 | 000 |
| 10813040013346 | K183453 | 000 |
| 10813040013339 | K183453 | 000 |
| 18130400103533 | K183453 | 000 |
| 10813040013742 | K183453 | 000 |
| 10813040013322 | K183453 | 000 |
| 10813040013254 | K183453 | 000 |