Data / Medical devices / United States / Exergen Corporation Leominster Warehouse
Exergen Corporation Leominster Warehouse: FDA-registered device maker in Leominster, MA, United States, 3 510(k) clearances
Exergen Corporation Leominster Warehouse is registered with the FDA (registration 3017581269) in Leominster, MA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 12, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017581269
- Address
- 45 Francis St, Leominster, MA, United States, 01453
- Owner or operator
- Exergen Corporation (1221195)
- Roles
- Manufacturer
- First device listed
- April 29, 2008
- Registered through
- 2026
- Brand names listed
- Ear/Tympanic thermometer models, Skin Temperature Scanner models, TemporalScanner various models
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | 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 |
|---|---|---|---|---|---|---|
| July 12, 2001 | K011291 | TEMPORALSCANNER THERMOMETER, SENSORTOUCH | FLL | Substantially Equivalent | Exergen Corp. | accessdata.fda.gov |
| November 1, 1988 | K882949 | TYMPANIC TEMPERATURE SCANNER | FLL | Substantially Equivalent | Omega Medical Corp. | accessdata.fda.gov |
| November 17, 1987 | K873010 | SURFACE TEMPERATURE SCANNER | FLL | Substantially Equivalent | Omega Medical Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 12, 2001. 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.