SMART METER LLC

FDA Device Registration & Listing · Tampa, FL, US · Registration 3015109923

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015109923
FEI Number
3015109923
Entity Name
SMART METER LLC
City/State/Country
Tampa, FL, US
Establishment Address
6005 Benjamin Rd Ste A, Tampa, FL 33634, US
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Smart Meter LLC (Owner Number: 10061770)
Owner / Operator Contact Address
6005 Benjamin Road, Ste. A, Tampa, FL 33634, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K141160
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-05-29
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-07-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-14
DQA Oximeter Cardiovascular Class 2 870.2700 2023-07-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2026-02-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2026-01-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-01-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-14

Official Correspondent

Erez Pick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smart Meter LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015109923. Last updated year: 2026. Please use registration number 3015109923 when referencing this establishment in official correspondence.
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