Data / Medical devices / United States / usocmedical
usocmedical: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
usocmedical is registered with the FDA (registration 3009485437) in Irvine, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 30, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009485437
- Address
- 20 Morgan, Irvine, CA, United States, 92618
- Owner or operator
- USOC Medical (10043576)
- Roles
- Specification developer
- First device listed
- July 21, 2019
- Registered through
- 2027
- Brand names listed
- USOC Reusable SpO2 Sensor Nellcor Compatible, Adult Finger Clip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | 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 |
|---|---|---|---|---|---|---|
| January 30, 2019 | K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | DSA | Substantially Equivalent | Orantech, Inc. | accessdata.fda.gov |
| February 6, 2015 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | DQA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 2019. 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.