Data / Medical devices / United States / Ordinatrum Health
Ordinatrum Health: FDA-registered device maker in Tustin, CA, United States, 1 510(k) clearance
Ordinatrum Health is registered with the FDA (registration 3034603598) in Tustin, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034603598
- Address
- 2522 Chambers Rd Ste 216, Tustin, CA, United States, 92780
- Owner or operator
- Ordinatrum Health (10092246)
- Roles
- Manufacturer
- First device listed
- December 17, 2024
- Registered through
- 2026
- Brand names listed
- ARC Intensive Care Information System (ARC System)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 6, 2023 | K220117 | ARC Intensive Care Information System (ARC System) | MWI | Substantially Equivalent | Ordinatrum Solutions | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated June 6, 2023. 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.