FDA Registration
Active
🇺🇸 United States
EVOLU Non Contact Infrared Ear/Forehead Thermometer, PG-IRT1603
Reg #: 3027347051
·
FEI: 3027347051
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OVERSEAS CONSENSUS LLC
- Registration Number
- 3027347051
- FEI Number
- 3027347051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4 Peddlers Row, Unit 28
- City
- Newark
- State
- DE
- ZIP
- 19702
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182597
Owner / Operator
- Firm Name
- Overseas Consensus LLC
- Operator Number
- 10088003
- Address
- 4 Peddlers Row, Unit 28
- City
- Newark
- State
- DE
- Postal Code
- 19702
- Country
- US
- Correspondent
- Vladislavs Kuzmenko
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-05-13 |
Proprietary Names
EVOLU Non Contact Infrared Ear/Forehead Thermometer, PG-IRT1603
Establishment Types
Complaint File Establishment per 21 CFR 820.198