Data / Medical devices / United States / Spectron Ir
Spectron Ir: FDA-registered device maker in Medford, OR, United States, 2 510(k) clearances
Spectron Ir is registered with the FDA (registration 3007010903) in Medford, OR, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007010903
- Address
- 841 W Stewart Ave Ste 9, Medford, OR, United States, 97501
- Owner or operator
- Spectron IR (10028874)
- Roles
- Manufacturer
- First device listed
- April 8, 2011
- Registered through
- 2026
- Brand names listed
- Spectron IR Spectrum 9000 MB
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Telethermographic (Adjunctive Use) | LHQ | 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 |
|---|---|---|---|---|---|---|
| October 10, 2003 | K032471 | TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM | LHQ | Substantially Equivalent | Titronics Research & Development Co. | accessdata.fda.gov |
| November 14, 2002 | K023434 | DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM | LHQ | Substantially Equivalent | Dorex, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2003. 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.