FDA Registration
Active
🇺🇸 United States
GARMIN INTERNATIONAL, INC.
Reg #: 1000500214
·
FEI: 1000500214
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GARMIN INTERNATIONAL, INC.
- Registration Number
- 1000500214
- FEI Number
- 1000500214
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1200 E 151st St
- City
- Olathe
- State
- KS
- ZIP
- 66062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221774
Owner / Operator
- Firm Name
- Garmin International, Inc.
- Operator Number
- 10050272
- Address
- 1200 East 151st Street
- City
- Olathe
- State
- KS
- Postal Code
- 66062
- Country
- US
- Correspondent
- Travis Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2023-01-17 |
Establishment Types
Manufacture Medical Device