The following data is part of a premarket notification filed by Medtronic Care Management Services with the FDA for Medtronic Commander Flex.
| Device ID | K191745 |
| 510k Number | K191745 |
| Device Name: | Medtronic Commander Flex |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Medtronic Care Management Services 7980 Century Boulevard Chanhassan, MN 55317 |
| Contact | Gordon Nelson |
| Correspondent | Charmaine Sutton The Tamarack Group - MPLS, LLC 2584 Upton Ave. So Minneapolis, MN 55405 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2020-05-15 |