Data / Medical devices / United Kingdom / Paxman Coolers Limited
Paxman Coolers Limited: FDA-registered device maker in Fenay Bridge, Huddersfield Kirklees, United Kingdom, 2 510(k) clearances
Paxman Coolers Limited is registered with the FDA (registration 3008938259) in Fenay Bridge, Huddersfield Kirklees, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 7, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008938259
- Address
- International House Penistone Road, Fenay Bridge, Huddersfield Kirklees, United Kingdom, HD8 0LE
- Owner or operator
- Paxman Coolers (10054996)
- Roles
- Manufacturer
- First device listed
- May 23, 2017
- Registered through
- 2026
- Brand names listed
- Paxman Scalp Cooler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scalp Cooling System | PMC | 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 |
|---|---|---|---|---|---|---|
| June 7, 2018 | K173032 | Paxman Scalp Cooler | PMC | Substantially Equivalent | Paxman Coolers Limited | accessdata.fda.gov |
| April 17, 2017 | K163484 | Paxman Scalp Cooler | PMC | Substantially Equivalent | Paxman Coolers Limited | accessdata.fda.gov |
Compare with other makers
Updated June 7, 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.