Data / Medical devices / United States / Smart Meter LLC
Smart Meter LLC: FDA-registered device maker in Tampa, FL, United States, 12 510(k) clearances
Smart Meter LLC is registered with the FDA (registration 3015109923) in Tampa, FL, United States. It lists 7 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015109923
- Address
- 6005 Benjamin Rd Ste A, Tampa, FL, United States, 33634
- Owner or operator
- Smart Meter LLC (10061770)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- July 14, 2023
- Registered through
- 2026
- Brand names listed
- Lancing Device, Pulse Oximeter, Single Use Lancets, iBlood Pressure, iBlood Pressure Classic, iBlood Pressure Classic - Multi Cuff Device, iBlood Pressure Plus, iBlood Pressure Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 2024 | K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| April 29, 2024 | K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 28, 2023 | K223722 | MIO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Mio Labs, Inc. | accessdata.fda.gov |
| October 12, 2022 | K221913 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Alicn Medical Shenzhen, Inc. | accessdata.fda.gov |
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| August 30, 2022 | K221970 | Lancing device | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| April 4, 2018 | K172141 | Pulse Oximeter | DQA | Substantially Equivalent | Shanghai Berry Electronic Tech Co., Ltd. | accessdata.fda.gov |
| March 14, 2018 | K172795 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| February 21, 2018 | K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | DXN | Substantially Equivalent | Honsun (Nantong) Co., Ltd. | accessdata.fda.gov |
| May 2, 2017 | K161790 | iGlucose Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| October 7, 2014 | K141160 | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Oximeter
- All makers of Glucose Oxidase, Glucose
Updated November 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.