Data / Medical devices / United States / Medtronic Care Management Services
Medtronic Care Management Services: FDA-registered device maker in Lafayette, CO, United States, 1 510(k) clearance
Medtronic Care Management Services is registered with the FDA (registration 3004594267) in Lafayette, CO, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004594267
- Address
- 200 Medtronic Dr, Lafayette, CO, United States, 80026
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 2, 2016
- Registered through
- 2026
- Brand names listed
- Blood Pressure Cuff - Large Cuff Contour, Blood Pressure Cuff - Large Cuff Regular, Blood Pressure Cuff - Medium Cuff Contour, Blood Pressure Cuff - Medium Cuff Regular, Blood Pressure Cuff - Small Cuff Regular, Commander Flex CD320, ForaCare Blue Tooth Weight Scale Test n Go 550, Generic cables to connect Commander hub devices to Pulse Oximeter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2009 | K091821 | COMMANDER 111, MODEL CD300-CD399 | DXN | Substantially Equivalent | Cardiocom, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Scale, Stand-On, Patient
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
Updated August 25, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.