Data / Medical devices / United States / Amphenol Thermometrics, Inc.
Amphenol Thermometrics, Inc.: FDA-registered device maker in Saint Marys, PA, United States, 1 510(k) clearance
Amphenol Thermometrics, Inc. is registered with the FDA (registration 3008956776) in Saint Marys, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 24, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008956776
- Address
- 967 Windfall RD, Saint Marys, PA, United States, 15857
- Owner or operator
- Amphenol Thermometrics, Inc. (10052376)
- Roles
- Repackager or relabeler
- First device listed
- August 28, 2020
- Registered through
- 2026
- Brand names listed
- ADVANCE IR TSCAN-450
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 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 |
|---|---|---|---|---|---|---|
| June 24, 2008 | K081160 | AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES | FLL | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 24, 2008. 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.