FDA Registration
Active
🇺🇸 United States
ATMO Gas Capsule System
Reg #: 3017496797
·
FEI: 3017496797
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Kuro Medical
- Registration Number
- 3017496797
- FEI Number
- 3017496797
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7625 Golden Triangle Dr Ste G
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250940
Owner / Operator
- Firm Name
- One Life Sciences, Inc.
- Operator Number
- 10078335
- Address
- 7625 Golden Triangle Dr, Ste G
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Matt Kyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gastrointestinal Motility System, Capsule | NYV | Class 2 | Gastroenterology, Urology | No | 2025-07-01 |
Proprietary Names
ATMO Gas Capsule System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)