Data / Medical devices / United States / Clinical Computer Systems, Inc.
Clinical Computer Systems, Inc.: FDA-registered device maker in Hoffman Est, IL, United States, 1 510(k) clearance
Clinical Computer Systems, Inc. is registered with the FDA (registration 3004423584) in Hoffman Est, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 14, 2012. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004423584
- Address
- 2895 Greenspoint Pkwy, Suite 650, Hoffman Est, IL, United States, 60169
- Owner or operator
- CLINICAL COMPUTER SYSTEMS, INC. (9070701)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 30, 2014
- Registered through
- 2027
- Brand names listed
- OBIX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | 2 | Complaint file establishment, 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 14, 2012 | K121208 | OBIX PERINATAL DATA SYSTEM 7.0 | HGM | Substantially Equivalent | Clinical Computer Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 14, 2012. 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.