FDA Registration
Active
🇲🇾 Malaysia
ACUSON P500 Ultrasound System
Reg #: 3006786907
·
FEI: 3006786907
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Plexus Manufacturing Sdn .Bhd.
- Registration Number
- 3006786907
- FEI Number
- 3006786907
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 87, 88 & 89 Lebuhraya Kampung Jawa,
- City
- Bayan Lepas Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K213487
Owner / Operator
- Firm Name
- PLEXUS CORP.
- Operator Number
- 3019588
- Address
- ONE PLEXUS WAY, --
- City
- Neenah
- State
- WI
- Postal Code
- 54956
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-11-28 |
Proprietary Names
ACUSON P500 Ultrasound System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)