Data / Medical devices / United States / Starkey Global Distribution Center
Starkey Global Distribution Center: FDA-registered device maker in Plainfield, IN, United States, 2 510(k) clearances
Starkey Global Distribution Center is registered with the FDA (registration 3019622583) in Plainfield, IN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019622583
- Address
- 3810 Plainfield Road, Suite#112, Plainfield, IN, United States, 46168
- Owner or operator
- Starkey Laboratories, Inc. (2125608)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 12, 2007
- Registered through
- 2026
- Brand names listed
- AMP, AMPLI-MINI E 7S, AMPLI-MINI Signature Series, AMPLI-TV 2 LE ST, AMPLITV Streamer, AUDIBEL INTRIGUE AI, AUDIGY AGXS GENESIS AI, AUDIOSYNC INTRIGUE AI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 2 | Manufacturer, 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 19, 2020 | K201370 | Multiflex Tinnitus Technology | KLW | Substantially Equivalent | Starkey Laboratories, Inc. | accessdata.fda.gov |
| October 31, 2012 | K122876 | MULTIFLEX TINNITUS TECHNOLOGY | KLW | Substantially Equivalent | Starkey Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Masker, Tinnitus
Updated June 19, 2020. 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.