Data / Medical devices / United States / 3T Medical Systems Inc.
3T Medical Systems Inc.: FDA-registered device maker in Edison, NJ, United States, 5 510(k) clearances
3T Medical Systems Inc. is registered with the FDA (registration 1836518) in Edison, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1836518
- FEI number
- 3003261020
- Address
- 236 Fernwood Ave, Edison, NJ, United States, 08837
- Owner or operator
- 3T MEDICAL SYSTEMS, Inc (9043935)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 18, 2018
- Registered through
- 2026
- Brand names listed
- Altrix Temperature Management Wraps, Ambulating Bulb, ConstaVac CBC ll Blood Conservation Kit, Mul-T Blanket, RAPR ROUND, Thermal Regulating System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 10, 2018 | K180834 | Altrix Precision Temperature Management System | DWJ | Substantially Equivalent | Stryker Medical | accessdata.fda.gov |
| July 18, 2017 | K171149 | Altrix Temperature Management Wraps | DWJ | Substantially Equivalent | Stryker Medical | accessdata.fda.gov |
| December 2, 2016 | K152266 | Altrix Precision Temperature Management System | DWJ | Substantially Equivalent | Stryker Medical | accessdata.fda.gov |
| January 20, 2011 | K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | DWJ | Substantially Equivalent | Gaymar Industries, Inc. | accessdata.fda.gov |
| December 16, 1997 | K970714 | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) | CAC | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Continuous Measurement Thermometer
- All makers of Apparatus, Autotransfusion
Updated August 10, 2018. 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.