FDA Registration
Active
🇺🇸 United States
HydroMax HMEF
Reg #: 3020614
·
FEI: 3020614
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- A-M Systems
- Registration Number
- 3020614
- FEI Number
- 3020614
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 131 BUSINESS PARK LOOP
- City
- Sequim
- State
- WA
- ZIP
- 98382
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130664
Owner / Operator
- Firm Name
- A-M SYSTEMS, LLC
- Operator Number
- 3020614
- Address
- 131 BUSINESS PARK LOOP
- City
- Sequim
- State
- WA
- Postal Code
- 98382
- Country
- US
- Correspondent
- ROBERT J THOMPSON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2013-07-24 |
Proprietary Names
HydroMax HMEF
Establishment Types
Manufacture Medical Device