FDA Registration
Active
🇺🇸 United States
EKLA FINGER PULSE OXIMETER, E02-1001
Reg #: 3008733163
·
FEI: 3008733163
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EKLA CORPORATION
- Registration Number
- 3008733163
- FEI Number
- 3008733163
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1707 Quincy Ave Ste 127
- City
- Naperville
- State
- IL
- ZIP
- 60540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163135
Owner / Operator
- Firm Name
- EKLA Corporation
- Operator Number
- 10035863
- Address
- 1707 Quincy Ave. Suite 127
- City
- Naperville
- State
- IL
- Postal Code
- 60540
- Country
- US
- Correspondent
- Erin Lu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-01-21 |
Proprietary Names
EKLA FINGER PULSE OXIMETER, E02-1001
NOVAPLUS FINGER PULSE OXIMETER, V02-1001
Establishment Types
Repack or Relabel Medical Device