FDA Registration
Inactive
🇦🇺 Australia
Atmo Gas Capsule System
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ATMO BIOSCIENCES LTD
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 436 Elgar Rd
- City
- Box Hill Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K250940
Owner / Operator
- Firm Name
- Atmo Biosciences Ltd
- Operator Number
- 10093741
- Address
- 436 Elgar Rd
- City
- Box Hill
- State
- Victoria
- Postal Code
- 3128
- Country
- AU
- Correspondent
- Ian Macfarlane
US Agent
- Business Name
- Kuro Medical LLC
- Contact Name
- Matt Kyle
- Address
- 7625 Golden Triangle Dr Ste G
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
- [email protected]
- Phone
- 612 6362035
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