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 |