Data / Medical devices / United States / Truer Medical, Inc.
Truer Medical, Inc.: FDA-registered device maker in Orange, CA, United States, 2 510(k) clearances
Truer Medical, Inc. is registered with the FDA (registration 2032273) in Orange, CA, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032273
- FEI number
- 3003240904
- Address
- 1050 N Batavia St Ste C, Orange, CA, United States, 92867
- Owner or operator
- TRUER MEDICAL, INC. (9043471)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- October 26, 2000
- Registered through
- 2027
- Brand names listed
- 400 Series Type Monitor Cable, Right Angle, Esophageal Stethoscope, Gas Sampling Line, General Purpose Probes, Tympanic Probes, Skin Sensing Probes, HP 400 Series Type Monitor Cable, Intubation Stylet, Migratherapy LLC, Quick Spint and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bougie, Esophageal, Ent | KCD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Contract manufacturer | accessdata.fda.gov |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | 2 | Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | 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 |
|---|---|---|---|---|---|---|
| November 18, 2010 | K101244 | SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE | FLL | Substantially Equivalent | Truer Medical, Inc. | accessdata.fda.gov |
| September 17, 2009 | K092716 | ESOPHAGEAL STETHOSCOPE | BZT | Substantially Equivalent | Truer Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Stethoscope, Esophageal, With Electrical Conductors
- All makers of Tubing, Pressure And Accessories
- All makers of Stylet, Tracheal Tube
- All makers of Bougie, Esophageal, Ent
- All makers of Continuous Measurement Thermometer
Updated November 18, 2010. 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.