Data / Medical devices / United States / Tracelogix Corporation
Tracelogix Corporation: FDA-registered device maker in Memphis, TN, United States, 5 510(k) clearances
Tracelogix Corporation is registered with the FDA (registration 3009888765) in Memphis, TN, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 29, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009888765
- Address
- 3605 Knight Rd Ste 101, Memphis, TN, United States, 38118
- Owner or operator
- Tracelogix Corporation (10042306)
- Roles
- Repackager or relabeler
- First device listed
- November 12, 2012
- Registered through
- 2026
- Brand names listed
- Cable, Transducer and Electrode, Pateint, Including connector, Cuffs, Disposable Cuff, Oximeter, Temperature Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | 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 29, 2012 | K121427 | UNIMED TEMPERATURE PROBE | FLL | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| May 4, 2012 | K120364 | UNIMED DISPOSABLE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| November 22, 2011 | K112544 | UNIMED BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| December 2, 2008 | K082546 | REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) | DQA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS | DSA | Substantially Equivalent | Unimed Medical Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Blood Pressure Cuff
- All makers of Oximeter
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
Updated May 29, 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.