FDA Registration
Active
🇺🇸 United States
SMART METER LLC
Reg #: 3015109923
·
FEI: 3015109923
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- SMART METER LLC
- Registration Number
- 3015109923
- FEI Number
- 3015109923
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6005 Benjamin Rd Ste A
- City
- Tampa
- State
- FL
- ZIP
- 33634
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202891
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 |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2023-07-14 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-07-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-07-14 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2026-02-06 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2026-01-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2023-07-14 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-07-14 |
Proprietary Names
iBlood Pressure Classic
iBlood Pressure Classic - Multi Cuff Device
Lancing Device
iBlood Pressure
Pulse Oximeter
iGlucose Touch
iDigiTemp
iGlucose Essential
iBlood Pressure Plus
iBlood Pressure Pro
iGlucose Meter Kit
Single Use Lancets
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198