Data / Medical devices / United States / Garmin International, Inc.
Garmin International, Inc.: FDA-registered device maker in Olathe, KS, United States, 1 510(k) clearance
Garmin International, Inc. is registered with the FDA (registration 1000500214) in Olathe, KS, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1000500214
- Address
- 1200 E 151st St, Olathe, KS, United States, 66062
- Owner or operator
- Garmin International, Inc. (10050272)
- Roles
- Manufacturer
- First device listed
- January 17, 2023
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph Software For Over-The-Counter Use | QDA | 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 |
|---|---|---|---|---|---|---|
| January 12, 2023 | K221774 | Garmin ECG App | QDA | Substantially Equivalent | Garmin International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 12, 2023. 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.