FDA Registration
Active
🇺🇸 United States
Pulse Oximeter
Reg #: 3015109923
·
FEI: 3015109923
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SMART METER LLC
- Registration Number
- 3015109923
- FEI Number
- 3015109923
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6005 Benjamin Rd Ste A
- City
- Tampa
- State
- FL
- ZIP
- 33634
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172141
Owner / Operator
- Firm Name
- Smart Meter LLC
- Operator Number
- 10061770
- Address
- 6005 Benjamin Road, Ste. A
- City
- Tampa
- State
- FL
- Postal Code
- 33634
- Country
- US
- Correspondent
- Erez Pick
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-07-14 |
Proprietary Names
Pulse Oximeter
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198