Data / Medical devices / United States / Medipines Corporation
Medipines Corporation: FDA-registered device maker in Yorba Linda, CA, United States, 1 510(k) clearance
Medipines Corporation is registered with the FDA (registration 3015272694) in Yorba Linda, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015272694
- Address
- 22755 Savi Ranch Pkwy Ste C, Yorba Linda, CA, United States, 92887
- Owner or operator
- MediPines Corporation (10059619)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 4, 2019
- Registered through
- 2026
- Brand names listed
- MediPines Gas Exchange Monitor AGM100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Computer, Oxygen-Uptake | BZL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer, 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 11, 2019 | K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | CCK | Substantially Equivalent | Medipines Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Computer, Oxygen-Uptake
- All makers of Analyzer, Gas, Oxygen, Gaseous-Phase
Updated January 11, 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.