Data / Medical devices / United States / Medical Informatics Corp.
Medical Informatics Corp.: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Medical Informatics Corp. is registered with the FDA (registration 3010392999) in Houston, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 26, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010392999
- Address
- 7255 Helix Park Avenue Suite 1B, Houston, TX, United States, 77030
- Owner or operator
- Medical Informatics Corp. (10044938)
- Roles
- Manufacturer
- First device listed
- August 26, 2013
- Registered through
- 2027
- Brand names listed
- Patient Hx, Sickbay Clinical Platform
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 |
|---|---|---|---|---|---|---|
| May 26, 2015 | K143304 | Sickbay Clinical Platform | MWI | Substantially Equivalent | Medical Informatics Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Medical Device Data System
Updated May 26, 2015. 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.