Data / Medical devices / United States / Essef Distributor, Inc.
Essef Distributor, Inc.: FDA-registered device maker in Mineola, NY, United States, 1 510(k) clearance
Essef Distributor, Inc. is registered with the FDA (registration 2434115) in Mineola, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 20, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2434115
- Address
- 264 Herricks Rd, Mineola, NY, United States, 11501
- Owner or operator
- Essef Distributor, Inc. (10095024)
- Roles
- Repackager or relabeler
- First device listed
- January 15, 2026
- Registered through
- 2026
- Brand names listed
- Thermometer
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 |
|---|---|---|---|---|---|---|
| November 20, 2018 | K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 | FLL | Substantially Equivalent | Kangfu Medical Equipment Factory | accessdata.fda.gov |
Compare with other makers
Updated November 20, 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.