Data / Medical devices / United States / Resuscitation Innovations LLC dba AdvancedCPR Solutions
Resuscitation Innovations LLC dba AdvancedCPR Solutions: FDA-registered device maker in Edina, MN, United States, 1 510(k) clearance
Resuscitation Innovations LLC dba AdvancedCPR Solutions is registered with the FDA (registration 3012191403) in Edina, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012191403
- Address
- 5201 Eden Avenue Suite 300, Edina, MN, United States, 55436
- Owner or operator
- Resuscitation Innovations LLC (10050254)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 3, 2022
- Registered through
- 2026
- Brand names listed
- EleGARD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Board, Cardiopulmonary | FOA | 1 | 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 |
|---|---|---|---|---|---|---|
| July 29, 2022 | K221901 | EleGARD | FOA | Substantially Equivalent | Advancedcpr Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 29, 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.