Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000500214

FEI Number

1000500214

Entity Name

GARMIN INTERNATIONAL, INC.

City/State/Country

Olathe, KS, US

Establishment Address

1200 E 151st St, Olathe, KS 66062, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Garmin International, Inc. (Owner Number: 10050272)

Owner / Operator Contact Address

1200 East 151st Street, Olathe, KS 66062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221774

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	Class 2	870.2345	2023-01-17

Official Correspondent

Travis Johnson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Garmin International, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243236	Whoop., Inc.	WHOOP ECG (electrocardiogram) Feature (1.0)	2025-04-04

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3006371704	RR DONNELLEY-SUPPLY CHAIN SOLUTIONS	Plover, WI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000500214. Last updated year: 2026. Please use registration number 1000500214 when referencing this establishment in official correspondence.