Data / Medical devices / United States / Rising Eagle Medical
Rising Eagle Medical: FDA-registered device maker in Lafayette, CO, United States, 3 510(k) clearances
Rising Eagle Medical is registered with the FDA (registration 3021691064) in Lafayette, CO, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021691064
- Address
- 75 Waneka Parkway, Lafayette, CO, United States, 80026
- Owner or operator
- Rising Eagle Medical (10084422)
- Roles
- Complaint file establishment
- First device listed
- February 19, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| January 27, 2022 | K211941 | 9Line | DSA | Substantially Equivalent | Energetic Designs, Inc. | accessdata.fda.gov |
| June 8, 2018 | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | DQA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
| April 24, 2017 | K170536 | ECG Disposable Lead Wire | DSA | Substantially Equivalent | APK Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Ureteral Catheter
- All makers of Oximeter
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Cable, Electrode
Updated January 27, 2022. 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.