FDA Registration
Active
🇺🇸 United States
PARKS MEDICAL ELECTRONICS, INC.
Reg #: 3020115
·
FEI: 3020115
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- PARKS MEDICAL ELECTRONICS, INC.
- Registration Number
- 3020115
- FEI Number
- 3020115
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 19460 SW SHAW ST
- City
- ALOHA
- State
- OR
- ZIP
- 97007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K944495
Owner / Operator
- Firm Name
- PARKS MEDICAL ELECTRONICS, INC.
- Operator Number
- 9930003
- Address
- 19460 SOUTH WEST SHAW, --
- City
- Aloha
- State
- OR
- Postal Code
- 97007
- Country
- US
- Correspondent
- Chris - Elkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Heart Sound, Fetal, Ultrasonic | HEK | Class 2 | Obstetrics/Gynecology | No | 2008-03-20 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2008-03-20 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2008-03-20 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2008-03-20 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2008-03-20 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2008-03-20 |
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2008-03-20 |
Proprietary Names
641-A; 614-B; 611-L; 917
811-B; 811-BL; 811-BTS; 842; 909; 841-A; 801-B; 812; 840; 915-BL; 806-CB; 810-A; 810-B
2100-SX
Establishment Types
Manufacture Medical Device