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Data / Medical devices / Turkey / Alerkan Ltd

Alerkan Ltd: FDA-registered device maker in Saray-Kazan Ankara, Turkey, 1 510(k) clearance

Alerkan Ltd is registered with the FDA (registration 3009509998) in Saray-Kazan Ankara, Turkey. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009509998
Address
Keresteciler Sanayi Sitesi A. Menderes Bulvari No: 3, Saray-Kazan Ankara, Turkey, 06980
Owner or operator
ALERKAN Ltd (10039179)
Roles
Manufacturer
First device listed
December 14, 2011
Registered through
2026
Brand names listed
Alerkan Spirometry Filters, various sizes

Devices it lists

DeviceProduct codeClassRoleSource
Spirometer, DiagnosticBZG2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 20, 2011K111587ALERKAN SPIROMETRY FILTERBZGSubstantially EquivalentAlerkan, Ltd.accessdata.fda.gov

Compare with other makers

Updated October 20, 2011. 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.