FDA Registration
Active
🇺🇸 United States
AsepTech Portable RO+ System
Reg #: 1530185
·
FEI: 1000515504
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AMERIWATER LLC.
- Registration Number
- 1530185
- FEI Number
- 1000515504
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3345 Stop 8 Rd, Suite A
- City
- DAYTON
- State
- OH
- ZIP
- 45414
- Country
- US
Regulatory Submissions
- 510(k) Number
- K924695
Owner / Operator
- Firm Name
- AMERIWATER LLC
- Operator Number
- 9009428
- Address
- 3345 Stop 8 Rd, --
- City
- Dayton
- State
- OH
- Postal Code
- 45414
- Country
- US
- Correspondent
- BRIAN R BOWMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2013-10-31 |
Proprietary Names
AsepTech Portable RO+ System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device