FDA Registration
Active
🇺🇸 United States
Femoral Head/Neck Impactor
Reg #: 3009973336
·
FEI: 3009973336
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Engineered Medical Systems, LLC
- Registration Number
- 3009973336
- FEI Number
- 3009973336
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3325 Appling Rd
- City
- Bartlett
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113798
Owner / Operator
- Firm Name
- Engineered Medical Systems, LLC
- Operator Number
- 10042524
- Address
- 3325 Appling Road
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
- Correspondent
- Dwayne Wisham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2013-11-19 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-11-19 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2013-11-19 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2013-11-19 |
| Monitor, Apnea, Facility Use | FLS | Class 2 | Anesthesiology | No | 2013-11-19 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2013-11-19 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-11-19 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2013-11-19 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2013-11-19 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2013-11-19 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-11-19 |
Proprietary Names
Femoral Head/Neck Impactor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)